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Zuo J, Li H, Zhang S, Li P. Nonsteroidal Anti-inflammatory Drugs for the Prevention of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis. Dig Dis Sci 2024; 69:3134-3146. [PMID: 39102041 PMCID: PMC11415478 DOI: 10.1007/s10620-024-08565-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/05/2024] [Accepted: 07/11/2024] [Indexed: 08/06/2024]
Abstract
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) remains the most frequent and severe complication following ERCP, elevating both patient suffering and healthcare costs, and posing challenges to the advancement of ERCP techniques. Empirical evidence supports the prophylactic use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the prevention of PEP, especially in high-risk populations, as endorsed by both the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society for Gastrointestinal Endoscopy (ESGE). However, the prophylactic efficacy of NSAIDs in average-risk individuals, alongside the ideal drug selection, dosing, and timing of NSAID administration, remains to be elucidated. Furthermore, the synergistic preventive potential of NSAIDs when integrated with other interventions, such as hydration, pancreatic stenting, somatostatin administration, sublingual nitrate application, and epinephrine, warrants further clarification. In this paper, we conduct an exhaustive review of the prophylactic effect and clinical administration of NSAIDs for PEP. We comprehensively synthesize findings from clinical trials investigating NSAIDs, both in monotherapy and combination regimens, for PEP prevention. Additionally, we scrutinize the current landscape of NSAID usage in clinical practice and evaluate their cost-effectiveness. Future research should concentrate on refining NSAID prophylaxis strategies for PEP in patients at different risk levels, while also enhancing adherence to clinical guidelines and alleviating the issue of NSAID cost inflation.
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Affiliation(s)
- Jiaxuan Zuo
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, 95, Yongan Road, Xicheng District, Beijing, 100050, China
| | - Hengcun Li
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, 95, Yongan Road, Xicheng District, Beijing, 100050, China
| | - Shutian Zhang
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, 95, Yongan Road, Xicheng District, Beijing, 100050, China
| | - Peng Li
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, 95, Yongan Road, Xicheng District, Beijing, 100050, China.
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El Kurdi B, Imam Z, Abonofal A, Babar S, Shah P, Pannala R, Papachristou G, Echavarria J, Pisipati S, Jahangir S, Rajalingamgari P, Chang YHH, Singh VP. NSAIDs do not reduce severity among post-ERCP pancreatitis patients. Pancreatology 2024; 24:14-23. [PMID: 37981523 PMCID: PMC11298787 DOI: 10.1016/j.pan.2023.11.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/15/2023] [Revised: 10/05/2023] [Accepted: 11/01/2023] [Indexed: 11/21/2023]
Abstract
OBJECTIVE Non-steroidal anti-inflammatory drugs (NSAIDs) are the most studied chemoprophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). While previous systematic reviews have shown NSAIDs reduce PEP, their impact on moderate to severe PEP (MSPEP) is unclear. We conducted a systematic review and meta-analysis to understand the impact of NSAIDs on MSPEP among patients who developed PEP. We later surveyed physicians' understanding of that impact. DESIGN A systematic search for randomized trials using NSAIDs for PEP prevention was conducted. Pooled-prevalence and Odds-ratio of PEP, MSPEP were compared between treated vs. control groups. Analysis was performed using R software. Random-effects model was used for all variables. Physicians were surveyed via email before and after reviewing our results. RESULTS 7688 patients in 25 trials were included. PEP was significantly reduced to 0.598 (95%CI, 0.47-0.76) in the NSAIDs group. Overall burden of MSPEP was reduced among all patients undergoing ERCP: OR 0.59 (95%CI, 0.42-0.83). However, NSAIDs didn't affect the proportion of MSPEP among those who developed PEP (p = 0.658). Rectal Indomethacin and diclofenac reduced PEP but not MSPEP. Efficacy didn't vary by risk, timing of administration, or bias-risk. Survey revealed a change in the impression of the effect of NSAIDs on MSPEP after reviewing our results. CONCLUSIONS Rectal diclofenac or indomethacin before or after ERCP reduce the overall burden of MSPEP by reducing the pool of PEP from which it can arise. However, the proportion of MSPEP among patients who developed PEP is unaffected. Therefore, NSAIDs prevent initiation of PEP, but do not affect severity among those that develop PEP. Alternative modalities are needed to reduce MSPEP among patients who develop PEP.
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Affiliation(s)
- Bara El Kurdi
- Department of Internal Medicine East Tennessee State University, Johnson City, TN, USA; Division of Gastroenterology and Hepatology, University of Texas Health at San Antonio, TX, USA.
| | - Zaid Imam
- Division of Gastroenterology and Hepatology, William Beaumont Hospital, Royal Oak, MI, USA
| | - Abdulrahman Abonofal
- Department of Internal Medicine East Tennessee State University, Johnson City, TN, USA
| | - Sumbal Babar
- Department of Internal Medicine East Tennessee State University, Johnson City, TN, USA
| | - Pir Shah
- Division of Gastroenterology and Hepatology, University of Texas Health at San Antonio, TX, USA
| | - Rahul Pannala
- Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, AZ, USA
| | - Georgios Papachristou
- Division of Gastroenterology and Hepatology, The Ohio State University Wexner Medical Center, Columbus, OH, USA
| | - Juan Echavarria
- Division of Gastroenterology and Hepatology, University of Texas Health at San Antonio, TX, USA
| | - Sailaja Pisipati
- Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, AZ, USA
| | - Sarah Jahangir
- Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, AZ, USA
| | - Prasad Rajalingamgari
- Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, AZ, USA
| | - Yu-Hui H Chang
- Department of Biostatistics, Mayo Clinic Arizona, Scottsdale, AZ, USA
| | - Vijay P Singh
- Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, AZ, USA.
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Akshintala VS, Kanthasamy K, Bhullar FA, Sperna Weiland CJ, Kamal A, Kochar B, Gurakar M, Ngamruengphong S, Kumbhari V, Brewer-Gutierrez OI, Kalloo AN, Khashab MA, van Geenen EJM, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: an updated systematic review and meta-analysis of 145 randomized controlled trials. Gastrointest Endosc 2023; 98:1-6.e12. [PMID: 37004815 DOI: 10.1016/j.gie.2023.03.023] [Citation(s) in RCA: 40] [Impact Index Per Article: 20.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/04/2021] [Revised: 03/01/2023] [Accepted: 03/21/2023] [Indexed: 04/04/2023]
Abstract
BACKGROUND AND AIMS The incidence, severity, and mortality of post-ERCP pancreatitis (PEP) largely remain unknown with changing trends in ERCP use, indication, and techniques. We sought to determine the incidence, severity, and mortality of PEP in consecutive and high-risk patients based on a systemic review and meta-analysis of patients in placebo and no-stent arms of randomized control trials (RCTs). METHODS The MEDLINE, Embase, and Cochrane databases were searched from the inception of each database to June 2022 to identify full-text RCTs evaluating PEP prophylaxes. The incidence, severity, and mortality of PEP from the placebo or no-stent arms of RCTs were recorded for consecutive and high-risk patients. A random-effects meta-analysis for a proportions model was used to calculate PEP incidence, severity, and mortality. RESULTS One hundred forty-five RCTs were found with 19,038 patients in the placebo or no-stent arms. The overall cumulative incidence of PEP was 10.2% (95% confidence interval [CI], 9.3-11.3), predominantly among the academic centers conducting such RCTs. The cumulative incidences of severe PEP and mortality were .5% (95% CI, .3-.7) and .2% (95% CI, .08-.3), respectively, across 91 RCTs with 14,441 patients. The cumulative incidences of PEP and severe PEP were 14.1% (95% CI, 11.5-17.2) and .8% (95% CI, .4-1.6), respectively, with a mortality rate of .2% (95% CI, 0-.3) across 35 RCTs with 3733 patients at high risk of PEP. The overall trend for the incidence of PEP among patients randomized to placebo or no-stent arms of RCTs has remained unchanged from 1977 to 2022 (P = .48). CONCLUSIONS The overall incidence of PEP is 10.2% but is 14.1% among high-risk patients based on this systematic review of placebo or no-stent arms of 145 RCTs; this rate has not changed between 1977 and 2022. Severe PEP and mortality from PEP are relatively uncommon.
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Affiliation(s)
- Venkata S Akshintala
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
| | - Kavin Kanthasamy
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
| | - Furqan A Bhullar
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
| | | | - Ayesha Kamal
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
| | - Bharati Kochar
- Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts, USA
| | - Merve Gurakar
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
| | | | - Vivek Kumbhari
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
| | | | - Anthony N Kalloo
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
| | - Mouen A Khashab
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
| | - Erwin-Jan M van Geenen
- Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, Netherlands
| | - Vikesh K Singh
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
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ERDOĞAN Ç, GÜVEN İE, BAŞPINAR B, KILIÇ ZMY. Evaluation of pancreatic stent and/or suppository indomethacin efficacy in post ERCP pancreatitis prophylaxis: a single center experience. JOURNAL OF HEALTH SCIENCES AND MEDICINE 2023. [DOI: 10.32322/jhsm.1197804] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/08/2023] Open
Abstract
Aim: Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a serious complication of ERCP. In this study, we aimed to compare the use of rectal indomethacin, pancreatic stenting or both techniques for prevention of PEP.
Material and Method: Patients who underwent ERCP for the first time due to choledocholithiasis between January 2022 and June 2022 were retrospectively reviewed. The clinical findings, demographics, laboratory records, endoscopic intervention characteristics, whether rectal indomethacin was applied before the procedure, whether pancreatic stent was placed or not were evaluated.
Results: A total of 367 patients who underwent ERCP for the first time were included in the study. The mean age was 61 (28-92) years and 53.4% were female. In 124 (33.8%) patients, involuntary guide-wire insertion into the pancreatic duct occurred during canulation. Pancreatic stent was placed in 82 (22.3%) of the patients. Rectal indomethacin was administered to 288 patients (78.5%), while indomethacin could not be administered in 79 patients (21.5%), because they did not give consent. When patients with involuntarily pancreatic canulation were evaluated, the rate of PEP was 3.6% in the stented group, while it was 15.3% in the stent-free group (p
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Affiliation(s)
- Çağdaş ERDOĞAN
- SAĞLIK BİLİMLERİ ÜNİVERSİTESİ, ANKARA ŞEHİR SAĞLIK UYGULAMA VE ARAŞTIRMA MERKEZİ
| | - İbrahim Ethem GÜVEN
- SAĞLIK BİLİMLERİ ÜNİVERSİTESİ, ANKARA ŞEHİR SAĞLIK UYGULAMA VE ARAŞTIRMA MERKEZİ
| | - Batuhan BAŞPINAR
- SAĞLIK BİLİMLERİ ÜNİVERSİTESİ, ANKARA ŞEHİR SAĞLIK UYGULAMA VE ARAŞTIRMA MERKEZİ, DAHİLİ TIP BİLİMLERİ BÖLÜMÜ
| | - Zeki Mesut Yalın KILIÇ
- SAĞLIK BİLİMLERİ ÜNİVERSİTESİ, ANKARA ŞEHİR SAĞLIK UYGULAMA VE ARAŞTIRMA MERKEZİ, DAHİLİ TIP BİLİMLERİ BÖLÜMÜ
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Combined rectal indomethacin and intravenous saline hydration in post-ERCP pancreatitis prophylaxis. Arab J Gastroenterol 2022; 23:95-101. [DOI: 10.1016/j.ajg.2022.01.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/19/2021] [Revised: 01/07/2022] [Accepted: 01/22/2022] [Indexed: 11/22/2022]
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Márta K, Gede N, Szakács Z, Solymár M, Hegyi PJ, Tél B, Erőss B, Vincze Á, Arvanitakis M, Boškoski I, Bruno MJ, Hegyi P. Combined use of indomethacin and hydration is the best conservative approach for post-ERCP pancreatitis prevention: A network meta-analysis. Pancreatology 2021; 21:1247-1255. [PMID: 34353727 DOI: 10.1016/j.pan.2021.07.005] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/15/2021] [Revised: 07/19/2021] [Accepted: 07/20/2021] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Post-ERCP pancreatitis (PEP) is a life-threatening complication. Given the lack of a causative treatment for pancreatitis, it is of vital importance to minimize this risk of PEP. Multi-target preventive therapy may be the best choice for PEP prevention as disease development is multifactorial. AIM We aimed to assess the efficacy of a combination of indomethacin and hydration - type and amount - for PEP prevention via a network meta-analysis. METHODS Through a systematic search in three databases, we searched all randomized controlled trials involving hydration and indomethacin and ranked the PEP preventive efficacy with a Bayesian network meta-analysis using the PRISMA for Network Meta-Analyses (PRISMA-NMA) guideline. The RoB2 tool was used for risk of bias assessment, surface under the cumulative ranking curve (SUCRA) for ranking and PROSPERO for the study protocol [reg. no. CRD42018112698]. We used risk ratios (RR) for dichotomous data with 95% credible intervals (95% CrI). RESULTS The quantitative analysis included 7559 patients from 24 randomized controlled trials. Based on the SUCRA values, a combination of lactated Ringer's and indomethacin is more effective than single therapy with a 94% certainty. The percent relative risk ratios estimate preventive efficacy 70-99% higher for combinations than single therapies. Aggressive hydration with indomethacin (SUCRA 100%) is also significantly more effective than all other interventions (percent relative effect 94.3-98.1%). CONCLUSIONS A one-hit-on-each-target therapeutic approach is recommended in PEP prevention with an easily accessible combination of indomethacin and aggressive hydration for all average and high-risk patients without contraindication.
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Affiliation(s)
- Katalin Márta
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary
| | - Noémi Gede
- Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary; Institute of Bioanalysis, Medical School, University of Pécs, Pécs, Hungary
| | - Zsolt Szakács
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Margit Solymár
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Péter Jenő Hegyi
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Bálint Tél
- First Department of Pediatrics, Semmelweis University, Budapest, Hungary
| | - Bálint Erőss
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Áron Vincze
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary
| | - Marianna Arvanitakis
- Gastroenterology Department, Gastrointestinal Cancer Unit, Erasme Hospital University, Brussels, Belgium
| | - Ivo Boškoski
- Centre for Endoscopic Research Therapeutics and Training (CERTT), Università Cattolica del Sacro Cuore, Italy
| | - Marco J Bruno
- Department of Gastroenterology & Hepatology, Erasmus Medical Center, University Medical Center Rotterdam, the Netherlands
| | - Péter Hegyi
- Institute for Translational Medicine, Szentágothai Research Centre, Medical School, University of Pécs, Pécs, Hungary; Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University, Budapest, Hungary; Centre for Translational Medicine, Semmelweis University, Budapest, Hungary.
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Yu S, Shen X, Li L, Bi X, Chen P, Wu W. Rectal indomethacin and diclofenac are equally efficient in preventing pancreatitis following endoscopic retrograde cholangiopancreatography in average-risk patients. JGH Open 2021; 5:1119-1126. [PMID: 34621996 PMCID: PMC8485396 DOI: 10.1002/jgh3.12643] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/23/2021] [Accepted: 08/04/2021] [Indexed: 11/22/2022]
Abstract
Rectal indomethacin and diclofenac are promising drugs for prevention of post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). However, their prophylactic effect on PEP in average‐risk patients remains controversial. We performed a systematic review and meta‐analysis to assess the efficacy and safety of rectal indomethacin and diclofenac in average‐risk patients, and to indirectly compare the prophylactic effect of the two drugs. A comprehensive search of the PubMed, EMBASE, and Cochrane Library databases was performed to identify randomized controlled trials (RCTs) on rectal indomethacin or diclofenac for prophylaxis against PEP. Fixed‐ and random‐effects models weighted by the Mantel–Haenszel method were used for direct comparisons. The adjusted indirect treatment comparison method was used to indirectly compare the efficacy of indomethacin and diclofenac. A total of 10 RCTs, including 2928 patients, met our inclusion criteria. No significant publication bias was identified. Pooled estimates showed that rectal indomethacin and diclofenac were associated with a significant reduction in the overall risk of PEP compared with control intervention [relative risk (RR) = 0.62; 95% confidence interval (CI): 0.46–0.83] in average‐risk patients. Subgroup analyses showed that both rectal indomethacin (RR = 0.67; 95% CI: 0.49–0.94) and diclofenac (RR = 0.42; 95% CI: 0.23–0.75) were effective in the prevention of PEP. Indirect comparison showed no significant difference between the effectiveness of the two drugs in the prevention of PEP (RR = 1.607; 95% CI: 0.824–3.136). The updated meta‐analysis suggests that both drugs provide equivalent protection against PEP in average‐risk patients.
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Affiliation(s)
- Shuang Yu
- Department of Gastroenterology Chongqing University Three Gorges Hospital Chongqing China
| | - Xumu Shen
- Department of Gastroenterology Chongqing University Three Gorges Hospital Chongqing China
| | - Liang Li
- Department of Gastroenterology Chongqing University Three Gorges Hospital Chongqing China
| | - Xiaofei Bi
- Department of Gastroenterology Chongqing University Three Gorges Hospital Chongqing China
| | - Ping Chen
- Department of Gastroenterology Chongqing University Three Gorges Hospital Chongqing China
| | - Wei Wu
- Department of Gastroenterology Chongqing University Three Gorges Hospital Chongqing China
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Dubravcsik Z, Hritz I, Keczer B, Novák P, Lovász BD, Madácsy L. Network meta-analysis of prophylactic pancreatic stents and non-steroidal anti-inflammatory drugs in the prevention of moderate-to-severe post-ERCP pancreatitis. Pancreatology 2021; 21:704-713. [PMID: 33926821 DOI: 10.1016/j.pan.2021.04.006] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2020] [Revised: 03/30/2021] [Accepted: 04/14/2021] [Indexed: 02/06/2023]
Abstract
BACKGROUND There is an ongoing debate that non-steroidal anti-inflammatory drugs (NSAID) or prophylactic pancreatic stents (PPS) are more beneficial in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). In our present network meta-analysis, we aimed to compare PPSs to rectal NSAIDs in the prevention of moderate and severe PEP in average- and high-risk patients. METHODS We performed a systematic search for randomized controlled trials (RCT) from MEDLINE (via PubMed), Embase and Cochrane Central databases. RCTs using prophylactic rectal NSAIDs or PPSs in patients subjected to ERCP at average- and high-risk population were included. The main outcome was moderate and severe PEP defined by the Cotton criteria. Pairwise Bayesian network meta-analysis was performed, and interventions were ranked based on surface under cumulative ranking (SUCRA) values. RESULTS Seven NSAID RCTs (2593 patients), and 2 PPS RCTs (265 patients) in the average-risk, while 5 NSAID RCTs (1703 patients), and 8 PPS RCTs (974 patients) in the high-risk group were included in the final analysis. Compared to placebo, only PPS placement reduced the risk of moderate and severe PEP in both patient groups (average-risk: RR = 0.07, 95% CI [0.002-0.58], high-risk: RR = 0.20, 95% CI [0.051-0.56]) significantly. Rectal NSAID also reduced the risk, but this effect was not significant (average-risk: RR = 0.58, 95% CI [0.22-1.3], high-risk: RR = 0.58, 95% CI [0.18-2.3]). Based on SUCRA, PPS placement was ranked as the best preventive method. CONCLUSION Prophylactic pancreatic stent placement but not rectal NSAID seems to prevent moderate-to-severe PEP better both, in average- and high-risk patients.
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Affiliation(s)
- Zsolt Dubravcsik
- Department of Gastroenterology, BKM Hospital, Kecskemét, Hungary.
| | - István Hritz
- Center for Therapeutic Endoscopy, 1st Department of Surgery, Semmelweis University, Budapest, Hungary
| | - Bánk Keczer
- Center for Therapeutic Endoscopy, 1st Department of Surgery, Semmelweis University, Budapest, Hungary
| | - Péter Novák
- Department of Gastroenterology, BKM Hospital, Kecskemét, Hungary
| | | | - László Madácsy
- Department of Gastroenterology, BKM Hospital, Kecskemét, Hungary; Endo-kapszula Private Medical Center, Székesfehérvár, Hungary
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Shou-xin Y, Shuai H, Fan-guo K, Xing-yuan D, Jia-guo H, Tao P, Lin Q, Yan-sheng S, Ting-ting Y, Jing Z, Fang L, Hao-liang Q, Man L. Rectal nonsteroidal anti-inflammatory drugs and pancreatic stents in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis in high-risk patients: A network meta-analysis. Medicine (Baltimore) 2020; 99:e22672. [PMID: 33080710 PMCID: PMC7571888 DOI: 10.1097/md.0000000000022672] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/15/2023] Open
Abstract
BACKGROUND 100 mg rectal nonsteroidal anti-inflammatory drugs (NSAIDs) and pancreatic stents both significantly reduce the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. Direct comparison of randomized controlled trials (RCTs) between them in high-risk patients is absent. We conducted this network meta-analysis to indirectly compare the efficacies of 100 mg rectal NSAIDs and pancreatic stents in preventing post-ERCP pancreatitis (PEP) in high-risk patients and help us decide which is preferred in clinical practice. METHODS A comprehensive search was done to identify RCTs published in English full-text. Interventions included 100 mg rectal NSAIDs (diclofenac or indomethacin) and pancreatic stents. Only studies with high-risk patients of PEP were included. Meta-analyses of NSAIDs and pancreatic stents were conducted respectively. A network meta-analysis using the Bayesian method was performed. RESULTS We included 14 RCTs, 8 on pancreatic stents and 6 on 100 mg rectal NSAIDs in high-risk patients. There was no direct comparison between them. After excluding an outlier study on NSAIDs (n = 144), meta-analyses showed they both significantly and statistically reduced the incidence of PEP in high-risk patients (pancreatic stents: n = 8 studies, random-effects risk ratio (RR)0.41, 95%CI 0.30-0.56, I = 0%; NSAIDs: n = 5 studies, random-effects RR 0.37, 95%CI 0.25-0.54, I = 0%). And network meta-analysis showed efficacy of 100 mg rectal NSAIDs was equal to pancreatic stents (random-effects RR 0.94, 95%CI 0.50-1.8). CONCLUSIONS The efficacy of 100 mg rectal NSAIDs (diclofenac or indomethacin) seems equally significant to pancreatic stents in preventing PEP in high-risk patients. Considering the cost-effectiveness and safety, 100 mg diclofenac or indomethacin may be preferred.
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Yang J, Wang W, Liu C, Zhao Y, Ren M, He S. Rectal Nonsteroidal Anti-Inflammatory Drugs for Endoscopic Retrograde Cholangiopancreatography Postoperative Pancreatitis Prevention: A Network Meta-Analysis. J Clin Gastroenterol 2020; 54:305-313. [PMID: 32011404 DOI: 10.1097/mcg.0000000000001322] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
Abstract
BACKGROUND Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication of ERCP procedure. Nonsteroidal anti-inflammatory drugs (NSAIDs) are reported to be one protective pharmacological agent with great efficacy regarding this complication. Recently, more trails have addressed this issue and some inconsistent results appeared. Therefore, this study aims to evaluate the efficacy and safety of different rectal NSAIDs schemes to prevent PEP. MATERIALS AND METHODS Eligible studies published on PubMed, the Cochrane Library, Embase, Web of Science before November 2018 were reviewed, and those which met the inclusion criteria were included in the analysis. The preventions were divided as placebo/no treatment, post-ERCP rectal diclofenac, pre-ERCP rectal diclofenac, post-ERCP rectal indomethacin, pre-ERCP rectal indomethacin, indomethacin using during ERCP, and pre-ERCP rectal naproxen. The main outcomes included the incidence of PEP and its severity. Other complications were also analyzed. RESULTS A total of 23 randomized controlled trials were included. The results of network meta-analysis illustrated that compared with the control, post-ERCP rectal diclofenac, pre-ERCP rectal diclofenac, and indomethacin were significantly associated with lower incidences of PEP. Moreover, it is notable that pre-ERCP rectal NSAIDs might reduce the severity of pancreatitis. Also, rectal NSAIDs may lead to less occurrence of asymptomatic hyperamylasemia. On the basis of the clustered ranking, pre-ERCP diclofenac appeared to be the superior intervention for PEP with satisfying efficacy. CONCLUSIONS The present study showed that pre-ERCP diclofenac is the optimal prevention method for PEP. However, more high quality head-to-head randomized controlled trials and observational studies are expected in the future.
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Affiliation(s)
- Jiahui Yang
- Department of Gastroenterology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an
| | - Wancong Wang
- Department of Gastroenterology, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, People's Republic of China
| | - Chuan Liu
- Department of Gastroenterology, The Fifth Affiliated Hospital of Zhengzhou University, Zhengzhou, People's Republic of China
| | - Yan Zhao
- Department of Gastroenterology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an
| | - Mudan Ren
- Department of Gastroenterology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an
| | - Shuixiang He
- Department of Gastroenterology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an
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Njei B, McCarty TR, Muniraj T, Sharma P, Jamidar PA, Aslanian HR, Varadarajulu S, Navaneethan U. Comparative effectiveness of pharmacologic and endoscopic interventions for prevention of post-ERCP pancreatitis: a network meta-analysis. Endosc Int Open 2020; 8:E29-E40. [PMID: 31921982 PMCID: PMC6949176 DOI: 10.1055/a-1005-6366] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/07/2019] [Accepted: 08/12/2019] [Indexed: 02/06/2023] Open
Abstract
Background and study aims While several interventions may decrease risk of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, it remains unclear whether one strategy is superior to others. The purpose of this study was to compare the effectiveness of pharmacologic and endoscopic interventions to prevent post-ERCP pancreatitis among high-risk patients. Methods A systematic review was performed to identify randomized controlled trials from PubMed, Embase, Web of Science, and Cochrane database through May 2017. Interventions included: rectal non-steroidal anti-inflammatory drugs (NSAIDs), aggressive hydration with lactated ringer's (LR) solution, and pancreatic stent placement compared to placebo. Only studies with patients at high-risk for post-ERCP pancreatitis were included. Bayesian network meta-analysis was performed and relative ranking of treatments was assessed using surface under the cumulative ranking (SUCRA) probabilities. Results We identified 29 trials, comprising 7,862 participants comparing four preventive strategies. On network meta-analysis, compared with placebo, rectal NSAIDs (B = - 0.69, 95 % CI [-1.18; - 0.21]), pancreatic stent (B = - 1.25, 95 % CI [-1.81 to -0.69]), LR (B = - 0.67, 95 % CI [-1.20 to -0.13]), and combination of LR plus rectal NSAIDs (B = - 1.58; 95 % CI [-3.0 to -0.17]), were all associated with a reduced risk of post-ERCP pancreatitis. Pancreatic stent placement had the highest SUCRA probability (0.81, 95 % CI [0.83 to 0.80]) of being ranked the best prophylactic treatment. Conclusions Based on this network meta-analysis, pancreatic stent placement appears to be the most effective preventive strategy for post-ERCP pancreatitis in high-risk patients.
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Affiliation(s)
- Basile Njei
- Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, United States
| | - Thomas R. McCarty
- Department of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital, Boston, Massachusetts, United States,Harvard Medical School, Boston, Massachusetts, United States
| | - Thiruvengadam Muniraj
- Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, United States
| | - Prabin Sharma
- Department of Gastroenterology and Hepatology, Yale New Haven Health-Bridgeport Hospital, Bridgeport, Connecticut, United States
| | - Priya A. Jamidar
- Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, United States
| | - Harry R. Aslanian
- Section of Digestive Diseases, Yale University School of Medicine, New Haven, Connecticut, United States
| | - Shyam Varadarajulu
- Center for Interventional Endoscopy, Florida Hospital, University of Central Florida College of Medicine, Orlando, Florida, United States
| | - Udayakumar Navaneethan
- Center for Interventional Endoscopy, Florida Hospital, University of Central Florida College of Medicine, Orlando, Florida, United States
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Nonsteroidal Anti-inflammatory Drugs for Endoscopic Retrograde Cholangiopancreatography Postoperative Pancreatitis Prevention: a Systematic Review and Meta-analysis. J Gastrointest Surg 2019; 23:1991-2001. [PMID: 30251071 DOI: 10.1007/s11605-018-3967-7] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/11/2018] [Accepted: 09/07/2018] [Indexed: 02/06/2023]
Abstract
BACKGROUND OR PURPOSE There is controversy regarding the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) for prophylaxis against endoscopic retrograde cholangiopancreatography (ERCP) postoperative pancreatitis. Therefore, we conducted a systematic review and meta-analysis to evaluate the efficacy of NSAIDs for prophylaxis against post-ERCP pancreatitis (PEP). METHODS PubMed, EMBASE, and Cochrane library databases were searched for relevant randomized controlled trials (RCTs). Selected RCTs were pooled under a fixed effects model to generate the relative risks (RRs) and their corresponding 95% confidence intervals (CIs). RESULTS Nineteen RCTs involving a total of 5031 patients (2555 in the intervention group and 2476 in the control group) were selected. Overall, NSAIDs were associated with a significant reduction in risk of PEP (RR = 0.54, 95% CI 0.45 to 0.64, I2 = 40.4%) and moderate to severe PEP (RR = 0.45, 95% CI 0.30 to 0.67, I2 = 0%) compared with the control group. Subgroup analyses were performed according to route of administration (rectal or other), type of NSAIDs (diclofenac, indomethacin, or other), timing of administration (pre-ERCP, post-ERCP, or other), and patient population (high risk or general). Subgroup analyses showed difference in clinical efficacy of NSAID prophylaxis regardless of route, timing, or specific type of NSAID. CONCLUSION NSAIDs were associated with a significant reduction in risk of PEP and moderate to severe PEP compared to the control group.
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Risk Factors for Post-ERCP Pancreatitis in High-Risk Patients Receiving Post-procedure Rectal Indomethacin. J Gastrointest Surg 2018; 22:1903-1910. [PMID: 29980976 DOI: 10.1007/s11605-018-3864-0] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/29/2018] [Accepted: 06/25/2018] [Indexed: 01/31/2023]
Abstract
BACKGROUND Post-ERCP pancreatitis (PEP) is the most common adverse event of ERCP. Rectal indomethacin has been widely administered to decrease the incidence of PEP in high-risk patients. However, it cannot completely prevent the occurrence of PEP. The purpose of the study was to evaluate the risk factors for PEP in high-risk patients receiving post-ERCP indomethacin. METHODS From June 2012 to July 2015, patients undergoing ERCP and at high risk for PEP in three tertiary hospitals in China were enrolled. All patients received indomethacin after the procedure. Patient-related and procedure-related risk factors for PEP were collected. Logistic regression analysis was used to investigate the risk factors. RESULTS Seven hundred ninety patients at high risk for PEP received post-ERCP indomethacin. The incidence of overall PEP and moderate-to-severe PEP was 8.0 and 1.5%, respectively. In multivariate analysis, suspected sphincter of Oddi dysfunction (SOD) (OR 2.73; 95%CI 1.38-5.43; p = 0.004), the presence of hilar obstruction (OR 4.53; 95%CI 1.60-12.81; p = 0.004), number of cannulation attempts ≥ 13 (OR 2.00; 95%CI 1.07-3.77; p = 0.030), inadvertent pancreatic duct (PD) cannulation ≥ 1 (OR 2.26; 95%CI 1.04-4.90; p = 0.040), and pancreatic contrast injections ≥ 1 (OR 2.30; 95%CI 1.02-5.23; p = 0.046) were high risk factors for overall PEP. For moderate-to-severe PEP, suspected SOD (OR 4.67; 1.19-18.35; p = 0.027), the presence of hilar obstruction (OR 7.95; 1.39-44.97; p = 0.010), and more cannulation attempts (OR 3.71; 1.09-12.65; p = 0.036) were three independent risk factors. CONCLUSIONS A substantial number of high-risk patients had PEP even receiving post-ERCP rectal indomethacin. The independent risk factors included suspected SOD, hilar stricture, more cannulation attempts, inadvertent PD cannulation, and PD contrast injections. TRIAL REGISTRATION NCT02709421.
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Lyu Y, Cheng Y, Wang B, Xu Y, Du W. What is impact of nonsteroidal anti-inflammatory drugs in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a meta-analysis of randomized controlled trials. BMC Gastroenterol 2018; 18:106. [PMID: 29973142 PMCID: PMC6032784 DOI: 10.1186/s12876-018-0837-4] [Citation(s) in RCA: 32] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/20/2017] [Accepted: 06/26/2018] [Indexed: 12/16/2022] Open
Abstract
Background Recently, although studies have investigated the role of NSAIDs in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), selection of the ideal drug, the time and route of its administration for the appropriate population remain controversial. Methods A systematic search was done in sources including PubMed, Embase, Web of Science, the Cochrane Library Central, and ClinicalTrials.gov from from August 1, 1990 to August 1, 2017. Randomized controlled trials comparing the prophylactic use of NSAIDs versus a placebo were included. Statistical analysis was performed using the RevMan 5.3 software to assess the outcomes. Results A total of 21 randomized controlled trials were included in the meta-analysis. Our study showed that NSAIDs significantly reduced the incidence of PEP (RR, 0.61, 95%CI,0.52–0.72; p < 0.00001). The analysis showed that indomethacin administration post-ERCP (RR, 0.47; 95% CI, 0.31–0.70; p = 0.0002) appeared to be more effective in preventing PEP than indomethacin administration pre-ERCP (RR, 0.59; 95% CI, 0.45–0.79; P = 0.0003), but there was no significant difference between the high-risk and average-risk population(p = 0.13). In the diclofenac group, it was noted that administration of diclofenac pre-ERCP (RR, 0.32; 95% CI, 0.16–0.63; p = 0.001) was more effective than that in post-ERCP (RR, 0.65; 95% CI, 0.27–1.599; p = 0.35). The relative risk of PEP was 0.63 (95% CI, 0.27–1.50; p = 0.30) in high-risk patients and 0.41 (95% CI, 0.17–0.98; p = 0.02) in average-risk patients. With regard to the route of administration, PEP decreased significantly only in patients receiving the drug rectally (RR, 0.53; 95% CI, 0.44–0.63; p < 0.00001), but not for those who received intramuscularly (RR, 0.74; 95% CI, 0.47–1.17; p = 0.20), intravenously (RR, 0.97; 95% CI, 0.51–1.83; p = 0.93), and orally (RR = 0.88; 95% CI, 0.55–0.1.43; p = 0.62). Conclusions Rectal administration of NSAIDs (both indomethacin and diclofenac) was effective in preventing PEP in unselected patients. A single dose of indomethacin after ERCP might be effective in preventing PEP in both high-risk and average-risk patients. However, diclofenac administered rectally before ERCP might be protective against PEP in high-risk patients compared to a placebo. However, more high quality head-to-head RCTs are required.
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Affiliation(s)
- Yunxiao Lyu
- Department of General Surgery, Dongyang people's Hospital, Dongyang, 322100, Zhejiang Province, China.
| | - Yunxiao Cheng
- Department of General Surgery, Dongyang people's Hospital, Dongyang, 322100, Zhejiang Province, China
| | - Bin Wang
- Department of General Surgery, Dongyang people's Hospital, Dongyang, 322100, Zhejiang Province, China
| | - Yueming Xu
- Department of General Surgery, Dongyang people's Hospital, Dongyang, 322100, Zhejiang Province, China
| | - Weibing Du
- Department of General Surgery, Dongyang people's Hospital, Dongyang, 322100, Zhejiang Province, China
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15
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Rectal Indomethacin Is Protective against Pancreatitis after Endoscopic Retrograde Cholangiopancreatography: Systematic Review and Meta-Analysis. Gastroenterol Res Pract 2018; 2018:9784841. [PMID: 29861721 PMCID: PMC5971281 DOI: 10.1155/2018/9784841] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/08/2017] [Accepted: 12/25/2017] [Indexed: 12/12/2022] Open
Abstract
Background and Aim Rectal indomethacin was reported to be effective for postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) prophylaxis. However, the preventive effect of indomethacin for average-risk patients remains unclear. Recently, some conflicting evidence was addressed by recent articles. We aimed to determine the protective role of indomethacin in PEP based on the latest available literature. Methods A systematic literature search was conducted using PubMed, Embase, Web of Science, and the Cochrane Library to identify related articles published before October 2016. Studies that evaluated the administration of indomethacin in the prevention of PEP were included in the analysis. We adopted a random-effects model to calculate the overall relative risk (RR) and 95% confidence interval (CI). Results Ten trials from an initial search were finally included in the meta-analysis. The administration of rectal indomethacin significantly reduced the incidence of PEP in consecutive ERCP population (RR, 0.63; 95% CI, 0.50–0.77). There was no significant heterogeneity across included studies (I2 = 14.2%, P = 0.31). Further subgroup analyses also revealed that rectal indomethacin could protect the individuals at high and average risks and reduced severity of PEP. Pre-ERCP administration of indomethacin seemed to be better than the post-ERCP given. There was no evidence of significant publication bias. Conclusions Rectal administration of indomethacin is an effective approach to prevent the incidence of PEP in both high- and average-risk populations undergoing ERCP. However, more high-quality RCTs are needed to further investigate the optimal timing for the administration of indomethacin.
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16
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Yaghoobi M, Alzahrani MA, McNabb-Baltar J, Martel M, Barkun AN. Rectal Indomethacin Prevents Moderate to Severe Post-ERCP Pancreatitis and Death and Should Be Used Before the Procedure: A Meta-Analysis of Aggregate Subgroup Data. J Can Assoc Gastroenterol 2018; 1:67-75. [PMID: 31294402 PMCID: PMC6487993 DOI: 10.1093/jcag/gwy006] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022] Open
Abstract
Background Despite overall evidence in the literature favoring rectal indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), its role in preventing potentially fatal complications is not well explored. Method A comprehensive electronic literature search was done to select randomized controlled trials (RCTs) comparing rectal indomethacin and placebo in preventing PEP. Methodological quality was assessed using the Cochrane risk of bias tool. Statistical heterogeneity was characterized. Random effect model meta-analysis was used. Several subgroup, sensitivity and aggregate subgroup data analyses were completed based on specific risk factors or patient characteristics to identify patient populations who may benefit most from rectal indomethacin. Results A total of eight out of 336 trials published between 2007 and 2016 (n=3324) were included. Analysis showed administering rectal indomethacin before rather than during or after ERCP significantly reduced PEP rates (odds ratio (OR): 0.56 [0.40-079]). Rectal indomethacin also significantly decreased the rate of moderate to severe PEP and death amongst all patients (OR: 0.53 [0.31-0.89] and 0.10 [0.02-0.65], respectively). Rectal indomethacin significantly prevented PEP in patients with sphincter of Oddi dysfunction (SOD) (OR: 0.49 [0.30-0.78]) and those undergoing biliary sphincterotomy (OR: 0.63 [0.42-0.95]), but not in those undergoing precut or pancreatic sphincterotomy or prophylactic pancreatic stent placement. Sensitivity analysis showed that the effect remained significant after two studies with high risk of bias were excluded. Conclusion Rectal indomethacin significantly decreases the occurrence of moderate to severe PEP and death in all patients, only if given before the procedure.
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Affiliation(s)
- Mohammad Yaghoobi
- Division of Gastroenterology, McMaster University, Hamilton, ON, Canada.,Cochrane Upper GI and Pancreatic Group, Hamilton, ON, Canada
| | | | - Julia McNabb-Baltar
- Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Myriam Martel
- Division of Gastroenterology, McGill University Health Sciences, Montreal QC, Canada
| | - Alan N Barkun
- Cochrane Upper GI and Pancreatic Group, Hamilton, ON, Canada.,Division of Gastroenterology, McGill University Health Sciences, Montreal QC, Canada
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17
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Garg R, Mohan BP, Krishnamoorthi R, Rustagi T. Pre-endoscopic retrograde cholangiopancreatography (ERCP) administration of rectal indomethacin in unselected patients to reduce post-ERCP pancreatitis: A systematic review and meta-analysis. Indian J Gastroenterol 2018; 37:120-126. [PMID: 29619673 DOI: 10.1007/s12664-018-0841-1] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2017] [Accepted: 03/02/2018] [Indexed: 02/04/2023]
Abstract
INTRODUCTION Previous studies have reported that peri-procedural administration of rectal indomethacin reduces the risk of pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). Based on these studies, gastrointestinal (GI) societies recommend prophylactic rectal indomethacin for all patients undergoing ERCP. However, recent studies have reported contradictory results. The aim of this study was to perform a systematic review and meta-analysis to estimate the pooled relative risk (RR) of post-ERCP pancreatitis (PEP) in unselected patients who received rectal indomethacin before the ERCP (pre-ERCP) compared to patients who received pre-ERCP rectal placebo. METHODS We conducted a comprehensive search of multiple electronic databases and conference proceedings (from inception through September 1, 2017) to identify randomized control trials (RCTs) investigating the role of pre-ERCP rectal indomethacin in reducing the risk of PEP in unselected patients undergoing ERCP. The databases included Ovid, Medline, In-Process, and Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, Scopus, and Web of Science. We calculated a pooled estimate of the RR of PEP in patients who received pre-ERCP rectal indomethacin compared to patients who received pre-ERCP rectal placebo. The meta-analysis was performed using the random effects model. RESULTS Six RCTs with a total of 2229 patients were included in the final meta-analysis. There were 1143 patients in the rectal indomethacin group and 1086 patients in the rectal placebo group. There were 71 events of PEP in the rectal indomethacin group and 114 events of PEP in the rectal placebo group. Pre-ERCP administration of rectal indomethacin significantly reduced the risk of PEP compared to pre-ERCP rectal placebo (RR 0.60, 95% CI, 0.45-0.80; p<0.0001). There was no heterogeneity between the studies (I2 = 0). CONCLUSION The results of this meta-analysis support the routine pre-ERCP administration of rectal indomethacin in unselected patients to prevent PEP.
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Affiliation(s)
- Rajat Garg
- Department of Internal Medicine, St. John Hospital and Medical Center, Detroit, MI, USA
| | - Babu P Mohan
- Department of Internal Medicine, University of Alabama, Tuscaloosa, AL, USA
| | - Rajesh Krishnamoorthi
- Department of Gastroenterology and Hepatology, Virginia Mason Medical Center, Seattle, WA, USA
| | - Tarun Rustagi
- Division of Gastroenterology and Hepatology, University of New Mexico, MSC10 5550, 1 University of New Mexico, Albuquerque, NM, 87131, USA.
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18
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Hatami B, Kashfi SMH, Abbasinazari M, Nazemalhosseini Mojarad E, Pourhoseingholi MA, Zali MR, Mohammad Alizadeh AH. Epinephrine in the Prevention of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Preliminary Study. Case Rep Gastroenterol 2018; 12:125-136. [PMID: 29805355 PMCID: PMC5968254 DOI: 10.1159/000479494] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2017] [Accepted: 07/10/2017] [Indexed: 01/01/2023] Open
Abstract
BACKGROUND Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) ranges between 15 and 20% among patients at high risk of developing PEP. The efficacy of indomethacin administration in the prevention of PEP is rather debatable. In the present randomized trial study, we evaluated whether or not the combination of indomethacin and epinephrine in comparison to the single administration of indomethacin differs in the pathogenesis and prevention of post-ERCP pancreatitis. PATIENTS AND METHODS One hundred and ninety-two patients were randomized in a double-blinded manner into 3 groups: the epinephrine group (group A), the indomethacin group (group B), and the combined epinephrine and indomethacin group (group C). After the procedure, patients were evaluated for the PEP development. RESULTS During the procedure, 66 patients were randomized to the epinephrine group (group A), 68 cases to the indomethacin group (group B), and 58 individuals to the indomethacin-epinephrine group (group C). The mean age of patients in the epinephrine group was 59.59 ± 15.680 years, in the indomethacin group it was 58.06 ± 17.125 years, and in the combination group it was 59.62 ± 15.369 years. In the present study, we did not observe a significant difference between the 3 groups in sex, age, pre-ERCP amylase, lipase, and patient and procedure risk factors including pancreatic duct (PD) dilation (p = 0.404), PD cannulation (p = 0.329), and difficult cannulation (p = 0.076) among others. PEP developed in 7 of the 192 individuals (3.6%), 6 PEP cases occurred in the indomethacin group and 1 in the epinephrine group (p = 0.016). Univariate analysis of risk factors for PEP in patients with and without pancreatitis revealed no significant difference between the pancreatitis group and the non-pancreatitis group. CONCLUSION In comparison to the administration of indomethacin alone, a single application of epinephrine and the combination of epinephrine and indomethacin seem to be effective in reducing the cases of PEP. A further randomized clinical trial with a larger sample size is required to confirm the efficacy of our medication in the prevention of pancreatitis after ERCP.
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Affiliation(s)
- Behzad Hatami
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Seyed Mohammad Hossein Kashfi
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammad Abbasinazari
- Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Ehsan Nazemalhosseini Mojarad
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammad Amin Pourhoseingholi
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mohammad Reza Zali
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Amir Houshang Mohammad Alizadeh
- Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
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19
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Yang C, Zhao Y, Li W, Zhu S, Yang H, Zhang Y, Liu X, Peng N, Fan P, Jin X. Rectal nonsteroidal anti-inflammatory drugs administration is effective for the prevention of post-ERCP pancreatitis: An updated meta-analysis of randomized controlled trials. Pancreatology 2017; 17:681-688. [PMID: 28734720 DOI: 10.1016/j.pan.2017.07.008] [Citation(s) in RCA: 30] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/20/2017] [Revised: 06/20/2017] [Accepted: 07/16/2017] [Indexed: 02/07/2023]
Abstract
BACKGROUND Acute pancreatitis is one of the most common complications of endoscopic retrograde cholangiopancreatography (ERCP). Whether the prophylactic administration of rectal non-steroidal anti-inflammatory drugs (NSAIDs) peri-ERCP is effective in preventing post-ERCP pancreatitis (PEP) remains controversial. The aim of this study was to assess the effect of rectal NSAIDs on PEP. METHODS A systematic search of literature databases (Cochrane Library, PubMed, EMBASE, and Web of Science) was performed to identify eligible randomized controlled trials (RCTs). The Jadad score for assessing risk of bias was used to evaluate the quality of included studies. The primary endpoint of the study was efficacy for PEP prevention. Sub-analyses were performed to determine the risk reduction for different NSAID types, for general vs. high-risk patients, by timing of administration and for moderate to severe PEP. RESULTS Twelve RCTs, including a total of 3989 patients, were identified and included in the analysis. The risk of PEP was lower in the NSAIDs group than in the placebo group (RR 0.52; 95% CI 0.43-0.64; P < 0.01). The risk of moderate to severe PEP was also lower in the NSAIDs group. (RR 0.44; 95% CI 0.28-0.69; P < 0.01). There was no difference in efficacy between rectal indomethacin and diclofenac, nor between pre-ERCP and post-ERCP administration timing of rectal NSAIDs. CONCLUSIONS A single rectal dose of NSAIDs is effective in preventing PEP both in high-risk and in unselected patients, regardless of timing of administration (pre- or post-ERCP) and NSAID type (indomethacin or diclofenac).
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Affiliation(s)
- Chong Yang
- Organ Transplantation Center, Hospital of the University of Electronic Science and Technology of China and Sichuan Provincial People's Hospital, Chengdu 610072, Sichuan, PR China
| | - Yanting Zhao
- Department of Health Education, Chengdu Centers for Diseases Control and Prevention, Chengdu 610041, Sichuan, PR China
| | - Wentao Li
- Organ Transplantation Center, Hospital of the University of Electronic Science and Technology of China and Sichuan Provincial People's Hospital, Chengdu 610072, Sichuan, PR China
| | - Shikai Zhu
- Organ Transplantation Center, Hospital of the University of Electronic Science and Technology of China and Sichuan Provincial People's Hospital, Chengdu 610072, Sichuan, PR China
| | - Hongji Yang
- Organ Transplantation Center, Hospital of the University of Electronic Science and Technology of China and Sichuan Provincial People's Hospital, Chengdu 610072, Sichuan, PR China
| | - Yu Zhang
- Organ Transplantation Center, Hospital of the University of Electronic Science and Technology of China and Sichuan Provincial People's Hospital, Chengdu 610072, Sichuan, PR China
| | - Xi Liu
- Department of Health Education, Chengdu Centers for Diseases Control and Prevention, Chengdu 610041, Sichuan, PR China
| | - Nan Peng
- Department of Health Education, Chengdu Centers for Diseases Control and Prevention, Chengdu 610041, Sichuan, PR China
| | - Ping Fan
- Department of Digestive Surgical Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei, PR China
| | - Xin Jin
- Department of Digestive Surgical Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei, PR China.
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Li L, Han Z, Yuan H, Zhang G, Jia Y, He C. Nonsteroidal anti-inflammatory drugs reduce the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis: a meta-analysis. JOURNAL OF HEPATO-BILIARY-PANCREATIC SCIENCES 2017; 24:520-529. [PMID: 28681997 DOI: 10.1002/jhbp.489] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
BACKGROUND Several recent studies suggested that nonsteroidal anti-inflammation drugs (NSAIDs) could prevent the pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, the routes of administration, the dosages of NSAIDs and the potential efficacy in reducing the severity of pancreatitis remain controversial. The aim of this meta-analysis was to evaluate the efficacy of NSAIDs for post-ERCP pancreatitis (PEP) prophylaxis. METHODS We systematically searched PubMed, Embase, EBSCO, Elsevier and Web of Science databases up to 1 October 2016 for relevant studies. RESULTS A total of 24 studies met the inclusion criteria. Compared to the controls, the risk of pancreatitis was much lower in the NSAIDs group (OR = 0.57, 95% CI: 0.48-0.67, P < 0.0001). However, NSAIDs were not effective in reducing the risk of moderate to severe pancreatitis compared with placebo (OR = 0.75, 95% CI: 0.57-1.00). In the subanalyses, rectal administration was the only effective route (OR = 0.51, 95% CI: 0.42-0.62), and the risk of PEP was reduced in both randomized controlled trials (RCTs) (OR = 0.63, 95% CI: 0.52-0.76) and case-control articles (C-Cs) (OR = 0.40, 95% CI: 0.28-0.58). CONCLUSIONS Prophylactic administration of NSAIDs reduced the incidence of PEP in both RCTs and C-Cs, especially when rectally administered, but was not effective in reducing the risk of moderate to severe pancreatitis.
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Affiliation(s)
- Lin Li
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Zhen Han
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Heming Yuan
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Guozheng Zhang
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Yuliang Jia
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
| | - Chiyi He
- Department of Gastroenterology, Yijishan Hospital of Wannan Medical College, Wuhu, Anhui, China
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Patai Á, Solymosi N, Mohácsi L, Patai ÁV. Indomethacin and diclofenac in the prevention of post-ERCP pancreatitis: a systematic review and meta-analysis of prospective controlled trials. Gastrointest Endosc 2017; 85:1144-1156.e1. [PMID: 28167118 DOI: 10.1016/j.gie.2017.01.033] [Citation(s) in RCA: 68] [Impact Index Per Article: 8.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/15/2016] [Accepted: 01/16/2017] [Indexed: 12/11/2022]
Abstract
BACKGROUND AND AIMS Diclofenac and indomethacin are the most studied drugs for preventing post-ERCP pancreatitis (PEP). However, there are no prospective, randomized multicenter trials with a sufficient number of patients for correct evaluation of their efficacy. Our aim was to evaluate all prospective trials published in full text that studied the efficacy of diclofenac or indomethacin and were controlled with placebo or non-treatment for the prevention of PEP in adult patients undergoing ERCP. METHODS Systematic search of databases (PubMed, Scopus, Web of Science, Cochrane) for relevant studies published from inception to 30 June 2016. RESULTS Our meta-analysis of 4741 patients from 17 trials showed that diclofenac or indomethacin significantly decreased the risk ratio (RR) of PEP to 0.60 (95% confidence interval [CI], 0.46-0.78; P = .0001), number needed to treat (NNT) was 20, and the reduction of RR of moderate to severe PEP was 0.64 (95% CI, 0.43-0.97; P = .0339). The efficacy of indomethacin compared with diclofenac was similar (P = .98). The efficacy of indomethacin or diclofenac did not differ according to timing (P = .99) or between patients with average-risk and high-risk for PEP (P = .6923). The effect of non-rectal administration of indomethacin or diclofenac was not significant (P = .1507), but the rectal route was very effective (P = .0005) with an NNT of 19. The administration of indomethacin or diclofenac was avoided in patients with renal failure. Substantial adverse events were not detected. CONCLUSIONS The use of rectally administered diclofenac or indomethacin before or closely after ERCP is inexpensive and safe and is recommended in every patient (without renal failure) undergoing ERCP. (Registration number: CRD42016042726, http://www.crd.york.ac.uk/prospero/.).
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Affiliation(s)
- Árpád Patai
- Department of Gastroenterology and Medicine, Markusovszky University Teaching Hospital, Szombathely, Hungary
| | - Norbert Solymosi
- Biometeorology Research Group, University of Veterinary Medicine, Budapest, Hungary
| | - László Mohácsi
- Department of Computer Science, Corvinus University of Budapest, Budapest, Hungary
| | - Árpád V Patai
- 2nd Department of Medicine, Semmelweis University, Budapest, Hungary
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Mok SRS, Ho HC, Shah P, Patel M, Gaughan JP, Elfant AB. Lactated Ringer's solution in combination with rectal indomethacin for prevention of post-ERCP pancreatitis and readmission: a prospective randomized, double-blinded, placebo-controlled trial. Gastrointest Endosc 2017; 85:1005-1013. [PMID: 27816497 DOI: 10.1016/j.gie.2016.10.033] [Citation(s) in RCA: 58] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/26/2016] [Accepted: 10/24/2016] [Indexed: 02/06/2023]
Abstract
BACKGROUND AND AIMS Prospective data have shown the benefit of rectal indomethacin (IND) for preventing post-ERCP pancreatitis (PEP). A recent pilot study demonstrated a lower incidence of PEP after an 8-hour lactated Ringer's solution (LR) infusion. The aim of this study was to evaluate the efficacy of IND with or without bolus LR in patients at high-risk for PEP. METHODS In this randomized, double-blinded, placebo-controlled trial we assigned patients to standard normal saline solution (NS) + placebo, NS + IND, LR + placebo, or LR + IND. Each liter of fluid infusion was completed within 30 minutes. Patients were determined high-risk based established criterion and excluded if they had pancreatitis, contraindications to IND, or signs of volume overload. Our primary outcome was PEP, defined by standardized criterion. Our secondary outcomes were severe acute pancreatitis, localized adverse events, death, length of stay, and readmission. RESULTS Our sample consisted of 192 patients (48 per group) who completed follow-up at 24 hours and at 30 days post-ERCP. All patients had at least 1 high-risk criterion for PEP, and 56% had >1. PEP occurred in 3 patients (6%) in the LR + IND versus 10 (21%) in the NS + placebo group (P = .04). Readmission rates were lower in the LR + IND group (1 [2%]) versus the NS + placebo group (6 [13%]; P = .03). No differences were found between the other study groups. There was 1 case of severe pancreatitis (NS + IND) and 1 case of pseudocyst (LR + IND). CONCLUSIONS In patients at high risk for PEP, LR + IND reduced the incidence of PEP and readmission rates compared with NS + placebo. (Clinical trial registration number: NCT02641561.).
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Affiliation(s)
- Shaffer R S Mok
- Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA
| | - Henry C Ho
- Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA
| | - Paurush Shah
- Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA
| | - Milan Patel
- Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA
| | - John P Gaughan
- Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA
| | - Adam B Elfant
- Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA
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Feng Y, Navaneethan U, Zhu X, Varadarajulu S, Schwartz I, Hawes R, Hasan M, Yang A. Prophylactic rectal indomethacin may be ineffective for preventing post-endoscopic retrograde cholangiopancreatography pancreatitis in general patients: A meta-analysis. Dig Endosc 2017; 29:272-280. [PMID: 27914176 DOI: 10.1111/den.12779] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2016] [Accepted: 11/28/2016] [Indexed: 12/20/2022]
Abstract
BACKGROUND AND AIM Efficacy of prophylactic indomethacin for prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in general patients remains controversial. To address this, we conducted a meta-analysis of clinical trials specifically on rectal indomethacin in prevention of PEP in consecutive patients undergoing ERCP. METHODS We searched MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases to identify randomized, double-blind, controlled clinical trials on rectal indomethacin in the prevention of PEP in consecutive patients undergoing ERCP. Primary outcome was the overall rate of PEP. Secondary outcomes were the overall rates of moderate to severe PEP and mild PEP. RESULTS Six studies, with a total of 2473 patients, were included. Overall rate of PEP was 7% (95% CI, 6-9%). No statistical difference was observed in overall rates of PEP (OR, 0.67; 95% CI, 0.46-1.00, P = 0.050) and, additionally, rates of moderate to severe (OR, 0.66; 95% CI, 0.28-1.56, P = 0.345) or mild (OR, 0.71; 95% CI, 0.45-1.10, P = 0.127) PEP between indomethacin and placebo. CONCLUSION In a contemporary meta-analysis of available randomized controlled trials of consecutive patients undergoing ERCP, rectal indomethacin did not show significant prevention effect of post-ERCP pancreatitis.
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Affiliation(s)
- Yunlu Feng
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA.,Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China
| | | | - Xiang Zhu
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA
| | | | - Ingrid Schwartz
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA.,Hospital Sao Lucas, Rio de Janeiro, Brazil
| | - Robert Hawes
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA
| | - Muhammad Hasan
- Center for Interventional Endoscopy, Florida Hospital, Orlando, USA
| | - Aiming Yang
- Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China
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Shen C, Shi Y, Liang T, Su P. Rectal NSAIDs in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis in unselected patients: Systematic review and meta-analysis. Dig Endosc 2017; 29:281-290. [PMID: 28112441 DOI: 10.1111/den.12816] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/04/2016] [Accepted: 01/18/2017] [Indexed: 02/06/2023]
Abstract
BACKGROUND AND AIM Efficacy of rectal non-steroidal anti-inflammatory drugs (NSAIDs) for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) prophylaxis in unselected patients remained controversial. The aim of the present study was to evaluate the efficacy of rectal NSAIDs in the prevention of PEP in unselected patients. METHODS An electronic literature search in the Cochrane Library, Embase, and PubMed was carried out for randomized controlled trials comparing rectal indomethacin or diclofenac with placebo in the prevention of PEP in unselected patients. Cochrane risk of bias tool was used to evaluate methodological quality. The data were carried out in forest plots using fixed-effect methods, and random-effect methods were used when heterogeneity was significant. RESULTS A total of nine trials were included in our final analysis. Rectal NSAIDs were effective to reduce the incidence of PEP in unselected patients (RR, 0.61; 95% CI, 0.46-0.79), especially for moderate-to-severe PEP (RR, 0.37; 95% CI, 0.17-0.79). Both indomethacin (RR, 0.67; 95% CI, 0.50-0.88) and diclofenac (RR, 0.29; 95% CI, 0.12-0.69) were significantly efficacious. Rectal NSAIDs given pre-ERCP showed significant efficacy (RR, 0.53; 95% CI, 0.39-0.71), whether when given within 30 min pre-ERCP (RR, 0.62; 95% CI, 0.42-0.92) or not (RR, 0.43; 95% CI, 0.28-0.67). CONCLUSION Rectal NSAIDs are effective in the prevention of PEP in unselected patients.
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Affiliation(s)
- Chongrong Shen
- The Second Clinical Medical School, Southern Medical University, Guangzhou City, China
| | - Yanqiang Shi
- The Second Clinical Medical School, Southern Medical University, Guangzhou City, China
| | - Tianyu Liang
- The Second Clinical Medical School, Southern Medical University, Guangzhou City, China
| | - Peizhu Su
- Department of Gastroenterology, First People's Hospital of Foshan Affiliated to Sun Yat-sen University, Foshan City, China
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Hou YC, Hu Q, Huang J, Fang JY, Xiong H. Efficacy and safety of rectal nonsteroidal anti-inflammatory drugs for prophylaxis against post-ERCP pancreatitis: a systematic review and meta-analysis. Sci Rep 2017; 7:46650. [PMID: 28440297 PMCID: PMC5404221 DOI: 10.1038/srep46650] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2016] [Accepted: 03/24/2017] [Indexed: 12/16/2022] Open
Abstract
Rectal nonsteroidal anti-inflammatory drugs (NSAIDs) are not commonly used clinically for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. To evaluate the efficacy and safety of NSAIDs for post-ERCP prophylaxis, we systematically reviewed sixteen randomized controlled trials (involving 6458 patients) that compared rectal NSAIDs with placebo or no treatment for post-ERCP pancreatitis prophylaxis updated to August 2016. GRADE framework was used to assess the quality of evidence. There was “high quality” evidence that rectal NSAIDs were associated with significant reduction in the risk of overall post-ERCP pancreatitis (RR, 0.55; 95% CI, 0.42–0.71). Subgroup analyses demonstrated that diclofenac (RR, 0.41; 95% CI, 0.19–0.90) was probably superior to indomethacin (RR, 0.58; 95% CI, 0.45–0.75), post-ERCP administration (RR, 0.46; 95% CI, 0.24–0.89) was probably superior to pre-ERCP (RR, 0.53; 95% CI, 0.42–0.67), and that mixed-risk population received more benefits (RR, 0.54; 95% CI, 0.33–0.88) than average-risk population (RR, 0.60; 95% CI, 0.41–0.88), but less than high-risk population (RR, 0.41; 95% CI, 0.19–0.91). Moreover, “high quality” evidence showed that rectal NSAIDs were safe when given as a standard dose (RR = 0.80; 95% CI, 0.47–1.36). In conclusion, this meta-analysis revealed that rectal NSAIDs are effective and safe in the prevention of post-ERCP pancreatitis in populations with all levels of risk.
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Affiliation(s)
- Yi-Chao Hou
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
| | - Qiang Hu
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
| | - Jiao Huang
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
| | - Jing-Yuan Fang
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
| | - Hua Xiong
- Division of Gastroenterology and Hepatology, Key Laboratory Gastroenterology and Hepatology, Ministry of Health, State Key Laboratory for Oncogenes and Related Genes, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai 200001, China
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Inamdar S, Han D, Passi M, Sejpal DV, Trindade AJ. Rectal indomethacin is protective against post-ERCP pancreatitis in high-risk patients but not average-risk patients: a systematic review and meta-analysis. Gastrointest Endosc 2017; 85:67-75. [PMID: 27612923 DOI: 10.1016/j.gie.2016.08.034] [Citation(s) in RCA: 49] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/01/2016] [Accepted: 08/23/2016] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Rectal indomethacin is a popular chemopreventive agent to help prevent post-ERCP pancreatitis (PEP). Previous meta-analyses have shown an overall protective effect for PEP in average-risk and high-risk patients. However, these meta-analyses are limited by a small number of studies. Recently, more trials have been published addressing this issue. The aim is to determine whether rectal indomethacin prevents PEP in average-risk and high-risk groups, after incorporating these new data. METHODS A comprehensive search of multiple literature databases in April 2016 was performed. Human prospective randomized controlled trials with placebo controls that examined the effect of rectally administered indomethacin on the incidence of PEP were included. RESULTS A total of 8 trials between 2007 and 2016 (n = 3778) were included. No significant publication bias existed. All studies used similar criteria to detect pancreatitis. Random effects model meta-analysis showed that the rate of PEP was significantly lower using indomethacin compared with placebo (relative risk, 0.43; 95% confidence interval, 0.28-0.65; P < .001) in high-risk patients. There was no significant statistical or clinical heterogeneity. Among average-risk patients, the rate of PEP was similar (non-significant) between the indomethacin and placebo groups (relative risk, 0.74; 95% confidence interval, 0.52-1.07; P = .115). The result of the main outcome remained robust in multiple sensitivity analyses. CONCLUSIONS Rectal indomethacin given before or after ERCP is protective against PEP in high-risk patients versus placebo; however, it is not protective in average-risk patients versus placebo.
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Affiliation(s)
- Sumant Inamdar
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
| | - Dennis Han
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
| | - Monica Passi
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
| | - Divyesh V Sejpal
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
| | - Arvind J Trindade
- Hofstra Northwell School of Medicine, Northwell Health System, Long Island Jewish Medical Center, New Hyde Park, New York, USA
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Ishiwatari H, Urata T, Yasuda I, Matsusaki S, Hisai H, Kawakami H, Ono M, Iwashita T, Doi S, Kawakubo K, Hayashi T, Sonoda T, Sakamoto N, Kato J. No Benefit of Oral Diclofenac on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis. Dig Dis Sci 2016; 61:3292-3301. [PMID: 27447477 DOI: 10.1007/s10620-016-4251-x] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/02/2016] [Accepted: 07/09/2016] [Indexed: 12/15/2022]
Abstract
BACKGROUND Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a serious complication. Rectal diclofenac (100 mg) has been shown to reduce the incidence of pancreatitis; however, this dosage form is unavailable in several countries. AIMS We aimed to investigate the preventive effect of oral diclofenac on pancreatitis after ERCP in a multicenter, randomized, prospective, placebo-controlled, double-blind trial. METHODS Patients undergoing a first ERCP in seven high-volume centers between July 2012 and August 2014 were considered eligible. Participants were administered oral diclofenac (50 mg) or placebo before and after ERCP. The primary endpoint was the incidence of pancreatitis. A subgroup analysis was performed for patients at high or low risk of pancreatitis. Secondary endpoints were pancreatic enzyme levels (amylase and lipase). RESULTS We initially enrolled 430 patients (216 in the diclofenac and 214 in the placebo group), and 23 were excluded after randomization. The overall incidence of pancreatitis was 9.8 % (20/205) and 9.4 % (19/202) in the diclofenac and placebo groups, respectively (p = 0.90). The incidence of pancreatitis was 20.3 % (13/64) and 21.3 % (13/61) in patients at high risk of pancreatitis (p = 0.78) and 5.0 % (7/141) and 4.3 % (6/141) in patients at low risk of pancreatitis in the diclofenac and placebo groups (p = 0.94), respectively. There were no significant differences in serum amylase and lipase levels between the two groups before and 24 h after ERCP. CONCLUSIONS Oral administration of diclofenac before and after ERCP showed no benefit in the prevention of pancreatitis. CLINICAL TRIALS REGISTRY NO UMIN000008109.
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Affiliation(s)
- Hirotoshi Ishiwatari
- Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan.
| | - Takahiro Urata
- Department of Gastroenterology, Japanese Red Cross Kumamoto Hospital, 1-1-2, Nagamineminami, Higashiku, Kumamoto, 861-8520, Japan
| | - Ichiro Yasuda
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3, Mizonokuchi, Takatsuku, Kawasaki, Kanagawa, 213-8507, Japan
| | - Shimpei Matsusaki
- Department of Gastroenterology, Suzuka General Hospital, 53-1275, Uyamanohana, Yasuzukacho, Suzuka, Mie, 513-8630, Japan
| | - Hiroyuki Hisai
- Department of Gastroenterology, Japanese Red Cross Date Hospital, 81, Suenagacho, Date, Hokkaido, 052-8511, Japan
| | - Hiroshi Kawakami
- Department of Gastroenterology and Hepatology, Center for Digestive Disease, University of Miyazaki, 5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki, 889-1692, Japan
| | - Michihiro Ono
- Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan
| | - Takuji Iwashita
- First Department of Internal Medicine, Gifu University Hospital, 1-1, Yanagito, Gifu, Gifu, 501-1194, Japan
| | - Shinpei Doi
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, 3-8-3, Mizonokuchi, Takatsuku, Kawasaki, Kanagawa, 213-8507, Japan
| | - Kazumichi Kawakubo
- Department of Gastroenterology and Hepatology, Hokkaido University Hospital, West 5, North 14, Kitaku, Sapporo, Hokkaido, 060-8648, Japan
| | - Tsuyoshi Hayashi
- Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan
| | - Tomoko Sonoda
- Department of Public Health, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan
| | - Naoya Sakamoto
- Department of Gastroenterology and Hepatology, Hokkaido University Hospital, West 5, North 14, Kitaku, Sapporo, Hokkaido, 060-8648, Japan
| | - Junji Kato
- Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South 1, West 16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan
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Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet 2016; 387:2293-2301. [PMID: 27133971 DOI: 10.1016/s0140-6736(16)30310-5] [Citation(s) in RCA: 132] [Impact Index Per Article: 14.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Rectal indometacin decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, the population most at risk and the optimal timing of administration require further investigation. We aimed to assess whether pre-procedural administration of rectal indometacin in all patients is more effective than post-procedural use in only high-risk patients to prevent post-ERCP pancreatitis. METHODS We did a multicentre, single-blinded, randomised controlled trial at six centres in China. Eligible patients with native papilla undergoing ERCP were randomly assigned in a 1:1 ratio (with a computer-generated list) to universal pre-procedural indometacin or post-procedural indometacin in only high-risk patients, with stratification by trial centres and block size of ten. In the universal indometacin group, all patients received a single dose (100 mg) of rectal indometacin within 30 min before ERCP. In the risk-stratified, post-procedural indometacin group, only patients at predicted high risk received rectal indometacin, immediately after ERCP. Investigators, but not patients, were masked to group allocation. The primary outcome was overall ocurrence of post-ERCP pancreatitis. The analysis followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT02002650. FINDINGS Between Dec 15, 2013, and Sept 21, 2015, 2600 patients were randomly assigned to universal, pre-procedural indometacin (n=1297) or risk-stratified, post-procedural indometacin (n=1303). Overall, post-ERCP pancreatitis occurred in 47 (4%) of 1297 patients assigned to universal indometacin and 100 (8%) of 1303 patients assigned to risk-stratified indometacin (relative risk 0·47; 95% CI 0·34-0·66; p<0·0001). Post-ERCP pancreatitis occurred in 18 (6%) of 305 high-risk patients in the universal group and 35 (12%) of 281 high-risk patients in the risk-stratified group (p=0·0057). Post-ERCP pancreatitis was also less frequent in average-risk patients in the universal group (3% [29/992]), in which they received indometacin, than in the risk-stratified group (6% [65/1022]), in which they did not receive the drug (p=0·0003). Other than pancreatitis, adverse events occurred in 41 (3%; two severe) patients in the universal indometacin group and 48 (4%; one severe) patients in the risk-stratified group. The most common adverse events were biliary infection (22 [2%] patients vs 33 [3%] patients) and gastrointestinal bleeding (13 [1%] vs ten [1%]). INTERPRETATION Compared with a risk-stratified, post-procedural strategy, pre-procedural administration of rectal indometacin in unselected patients reduced the overall occurrence of post-ERCP pancreatitis without increasing risk of bleeding. Our results favour the routine use of rectal indometacin in patients without contraindications before ERCP. FUNDING National Key Technology R&D Program, National Natural Science Foundation of China.
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Affiliation(s)
- Hui Luo
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Lina Zhao
- Department of Radiotherapy, Xijing Hospital, Fourth Military Medical University, Xi'an, China
| | - Joseph Leung
- Gastroenterology, Sacramento VA Medical Center, VANCHCS, Mather, and UC Davis Medical Center, Sacramento, CA, USA
| | - Rongchun Zhang
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Zhiguo Liu
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Xiangping Wang
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Biaoluo Wang
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Zhanguo Nie
- Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region, Urumqi, China
| | - Ting Lei
- Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region, Urumqi, China
| | - Xun Li
- The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China
| | - Wence Zhou
- The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China
| | - Lingen Zhang
- The Second Department of General Surgery, The First Hospital of Lanzhou University, Lanzhou, China
| | - Qi Wang
- Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, Yinchuan, China
| | - Ming Li
- Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University, Yinchuan, China
| | - Yi Zhou
- Department of Gastroenterology, No 451 Military Hospital, Xi'an, China
| | - Qian Liu
- Department of Gastroenterology, No 451 Military Hospital, Xi'an, China
| | - Hao Sun
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China
| | - Zheng Wang
- Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China
| | - Shuhui Liang
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Xiaoyang Guo
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Qin Tao
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Kaichun Wu
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
| | - Yanglin Pan
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
| | - Xuegang Guo
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China.
| | - Daiming Fan
- Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China
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Mukai S, Itoi T. Selective biliary cannulation techniques for endoscopic retrograde cholangiopancreatography procedures and prevention of post- endoscopic retrograde cholangiopancreatography pancreatitis. Expert Rev Gastroenterol Hepatol 2016; 10:709-22. [PMID: 26782710 DOI: 10.1586/17474124.2016.1143774] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Numerous endoscopic retrograde cholangiopancreatography (ERCP) techniques have been reported to achieve selective biliary cannulation success. For standard biliary cannulation procedures, the wire-guided cannulation technique has been reported to reduce the rate of post-ERCP pancreatitis (PEP) and increase the biliary cannulation success rate, although conflicting reports exist. The pancreatic or double-guidewire technique and several precut techniques have been reported as useful techniques in difficult biliary cannulation cases. Although ERCP is a useful endoscopic procedure, the risk of adverse events, particularly post-ERCP pancreatitis, is inevitable. Previous studies and analyses have revealed the risk factors for PEP. The efficacy of prophylactic pancreatic duct stent placement and the administration of rectal nonsteroidal anti-inflammatory drugs for preventing PEP has also been reported. Herein, we reviewed reports in the literature regarding the current status of selective biliary cannulation techniques and PEP prevention.
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Affiliation(s)
- Shuntaro Mukai
- a Department of Gastroenterology and Hepatology , Tokyo Medical University , Tokyo , Japan
| | - Takao Itoi
- a Department of Gastroenterology and Hepatology , Tokyo Medical University , Tokyo , Japan
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Sajid MS, Khawaja AH, Sayegh M, Singh KK, Philipose Z. Systematic review and meta-analysis on the prophylactic role of non-steroidal anti-inflammatory drugs to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis. World J Gastrointest Endosc 2015; 7:1341-1349. [PMID: 26722616 PMCID: PMC4689797 DOI: 10.4253/wjge.v7.i19.1341] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/09/2015] [Revised: 09/02/2015] [Accepted: 11/11/2015] [Indexed: 02/06/2023] Open
Abstract
AIM: To critically appraise the published randomized, controlled trials on the prophylactic effectiveness of the non-steroidal anti-inflammatory drugs (NSAIDs), in reducing the risk of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis.
METHODS: A systematic literature search (MEDLINE, Embase and the Cochrane Library, from inception of the databases until May 2015) was conducted to identify randomized, clinical trials investigating the role of NSAIDs in reducing the risk of post-ERCP pancreatitis. Random effects model of the meta-analysis was carried out, and results were presented as odds ratios (OR) with corresponding 95%CI.
RESULTS: Thirteen randomized controlled trials on 3378 patients were included in the final meta-analysis. There were 1718 patients in the NSAIDs group and 1660 patients in non-NSAIDs group undergoing ERCP. The use of NSAIDs (through rectal route or intramuscular route) was associated with the reduced risk of post-ERCP pancreatitis [OR, 0.52 (0.38-0.72), P = 0.0001]. The use of pre-procedure NSAIDs was effective in reducing approximately 48% incidence of post-ERCP pancreatitis, number needed to treat were 16 with absolute risk reduction of 0.05. But the risk of post-ERCP pancreattis was reduced by 55% if NSAIDs were administered after procedure. Similarly, diclofenac was more effective (55%) prophylactic agent compared to indomethacin (41%).
CONCLUSION: NSAIDs seem to have clinically proven advantage of reducing the risk of post-ERCP pancreatitis.
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Factors Affecting the Efficacy of Nonsteroidal Anti-inflammatory Drugs in Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Systematic Review and Meta-analysis. Pancreas 2015; 44:859-67. [PMID: 26168316 PMCID: PMC4824288 DOI: 10.1097/mpa.0000000000000326] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
OBJECTIVES To identify the factors affecting the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS We systematically searched databases for relevant studies published from inception to November 2013. RESULTS A meta-analysis of 11 randomized trials (n = 2497) revealed a significant reduction in PEP in patients who received NSAIDs compared with that in patients who received placebo (relative risk [RR], 0.59; 95% confidence interval [CI], 0.41-0.85; P = 0.005). In subgroup analysis by treatment type, indomethacin had no significant effect (RR, 0.66; 95% CI, 0.38-1.15; P = 0.14), whereas other NSAIDs showed significant benefit (RR, 0.51; 95% CI, 0.29-0.91; P = 0.02). Only rectal administration significantly reduced the incidence of PEP (RR, 0.43; 95% CI, 0.32-0.58; P < 0.00001). The risk for PEP was the lowest among patients who received NSAIDs before ERCP (RR, 0.48; 95% CI, 0.29-0.78; P = 0.003). NSAIDs did not significantly reduce the risk of PEP in men (RR, 0.61; 95% CI, 0.34-1.09), patients with sphincter of Oddi dysfunction (RR, 0.98; 95% CI, 0.38-2.54), or patients with pancreatic duct injection (RR, 0.64; 95% CI, 0.35-1.18). CONCLUSIONS Rectal administration of NSAIDs (especially diclofenac), before ERCP, seemed to be the most effective strategy for preventing PEP.
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Andrade-Dávila VF, Chávez-Tostado M, Dávalos-Cobián C, García-Correa J, Montaño-Loza A, Fuentes-Orozco C, Macías-Amezcua MD, García-Rentería J, Rendón-Félix J, Cortés-Lares JA, Ambriz-González G, Cortés-Flores AO, Alvarez-Villaseñor ADS, González-Ojeda A. Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial. BMC Gastroenterol 2015. [PMID: 26195123 PMCID: PMC4508969 DOI: 10.1186/s12876-015-0314-2] [Citation(s) in RCA: 60] [Impact Index Per Article: 6.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
Background Acute pancreatitis is the most common major complication after endoscopic retrograde cholangiopancreatography (ERCP). Many drugs have been evaluated for prophylaxis, including nonsteroidal anti-inflammatory drugs (NSAIDs), which are potent inhibitors of phospholipase A2 and play a role in the pathogenesis of acute pancreatitis. Rectal NSAIDs have been shown in prospective studies to decrease the incidence of this complication, but the indication is not generalized in clinical practice. The aim of this study was to evaluate the efficacy of rectal administration of indomethacin in reducing the incidence of post-ERCP pancreatitis in high-risk patients. Methods This was a controlled clinical trial where patients with an elevated risk of developing post-ERCP pancreatitis were assigned to receive 100 mg of rectal indomethacin or a 2.6 g suppository of glycerin immediately after ERCP, without placement of a pancreatic stent. The patients were determined to be at high risk based on validated patient- and procedure-related risk factors. Post-ERCP pancreatitis was defined as the presence of new upper abdominal pain, hyperamylasemia/hyperlipasemia (at least three times the upper limit) 2 hours after the procedure and hospitalization at least 48 hours because of the complication. Pancreatitis severity was defined according to Cotton’s criteria. Results One hundred sixty-six patients were included; 82 in the study group and 84 in the placebo group. Patients had at least one major and/or two minor risk factors for developing post-ERCP pancreatitis. The incidence of the complication was 4.87 % (4/82) in the study group and 20.23 % (17/84) in the placebo group; this difference was significant (P = 0.01). According to Cotton’s criteria, 17 patients (80.9 %) developed mild pancreatitis and 4 (19.1 %) had moderate pancreatitis; 3 of these 4 patients belonged to the placebo group (P = 0.60). Based on these results, an absolute risk reduction of 0.15 (15 %), a relative risk reduction of 0.75 (75 %) and a number needed to treat of 6.5 patients were calculated to prevent an episode of post-ERCP pancreatitis. There was no mortality. Conclusions Rectal indomethacin reduced the incidence of post-ERCP pancreatitis among patients at high risk of developing this complication. Trial registration National Clinical Trials NCT02110810. Date April 7, 2014.
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Affiliation(s)
- Víctor Fernando Andrade-Dávila
- Department Gastrointestinal Endoscopy, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México.
| | - Mariana Chávez-Tostado
- Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México.
| | - Carlos Dávalos-Cobián
- Department Gastrointestinal Endoscopy, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México.
| | - Jesús García-Correa
- Department Gastrointestinal Endoscopy, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México.
| | - Alejandro Montaño-Loza
- Department Gastrointestinal Endoscopy, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México.
| | - Clotilde Fuentes-Orozco
- Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México.
| | - Michel Dassaejv Macías-Amezcua
- Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México.
| | - Jesús García-Rentería
- Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México.
| | - Jorge Rendón-Félix
- Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México.
| | - José Antonio Cortés-Lares
- Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México.
| | - Gabriela Ambriz-González
- Department of Pediatric Surgery, Children's Hospital of the Western National Medical Center, Mexican Institute of Social Security, Guadalajara, Jalisco, México.
| | - Ana Olivia Cortés-Flores
- Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México.
| | | | - Alejandro González-Ojeda
- Research Unit in Clinical Epidemiology, Specialties Hospital of the Western National Medical Center, Mexican Institute of Social Security, CP 44340, Guadalajara, Jalisco, México.
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Isaji S, Takada T, Mayumi T, Yoshida M, Wada K, Yokoe M, Itoi T, Gabata T. Revised Japanese guidelines for the management of acute pancreatitis 2015: revised concepts and updated points. JOURNAL OF HEPATO-BILIARY-PANCREATIC SCIENCES 2015; 22:433-445. [PMID: 25904407 DOI: 10.1002/jhbp.260] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/09/2015] [Accepted: 04/10/2015] [Indexed: 02/06/2023]
Abstract
BACKGROUND Taking together the recent dramatic changes of the revised Atlanta classification and evidence newly obtained such as the role of step-up approach for necrotizing pancreatitis, the revision committee of the Japanese (JPN) Guidelines 2015 was prompted to perform an extensive revision of the guidelines. METHODS The JPN Guidelines 2015 was compared to the former edition 2010, and revision concepts and major revision points were reviewed. We compared the JPN 2015 with the other two guidelines, International Association of Pancreatology (IAP)/American Pancreas Association (APA) 2013 and American College of Gastroenterology (ACG) 2013, in order to clarify the distinct points. RESULTS The meta-analysis team conducted a new meta-analysis of four subjects that have been associated with conflicting results. It is apparent that the revised guidelines have been created more systematically and more objectively. As of antibiotics prophylaxis, its use in early phase (within 72 h of onset) for severe acute pancreatitis is recommended in JPN 2015 according to the results of original meta-analysis, whereas the other two guidelines do not recommend its routine use. An approach and management of local complications in necrotizing pancreatitis including infected necrosis are almost similar in the three guidelines. JPN 2015 alone emphasizes the implementation of the pancreatitis bundles that specify the management and treatment within the first 48 h after the onset of severe acute pancreatitis. CONCLUSION The JPN Guidelines 2015 prove to be the highest quality in terms of systematic literature review conducting original analyses by the meta-analysis team, determining the grading of recommendations and providing pancreatitis bundles.
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Affiliation(s)
- Shuji Isaji
- Hepatobiliary Pancreatic & Transplant Surgery, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan
| | - Tadahiro Takada
- Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan
| | - Toshihiro Mayumi
- Department of Emergency Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
| | - Masahiro Yoshida
- Department of Hemodialysis and Surgery, Chemotherapy Research Institute, International University of Health and Welfare, Ichikawa, Japan
| | - Keita Wada
- Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan
| | - Masamichi Yokoe
- General Internal Medicine, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan
| | - Takao Itoi
- Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan
| | - Toshifumi Gabata
- Department of Radiology, School of Medical Science, Kanazawa University, Kanazawa, Japan
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Effect of rectal indomethacin for preventing post-ERCP pancreatitis depends on difficulties of cannulation: results from a randomized study with sequential biliary intubation. J Clin Gastroenterol 2015; 49:429-37. [PMID: 25790233 DOI: 10.1097/mcg.0000000000000168] [Citation(s) in RCA: 46] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
GOALS AND BACKGROUND The greatest challenges for endoscopists performing biliary therapy in endoscopic retrograde cholangiopancreatography (ERCP) are to achieve selective biliary cannulation and prevent post-ERCP pancreatitis (PEP). Nonsteroidal anti-inflammatory drugs have proven prophylactic effect in PEP. However, the patient population that would benefit from this approach has not been defined. STUDY A total of 539 patients undergoing our cannulation protocol with early precut were randomized into a placebo-controlled, prospective, double-blind study to rectally receive either 100 mg indomethacin or placebo. The effect of indomethacin on PEP was stratified based on difficulties of cannulation and analyzed in patients with different risks. RESULTS In 70.3% of patients, biliary intubation was successful in the first 5 atraumatic attempts, PEP rate was low, and indomethacin was ineffective (7.4% in the placebo group and 5.2% in the indomethacin group, P=0.406). In the next phase of intubation using guidewire, the success rate increased up to 83.5%, and PEP rate rose up to 8.7%, the effect of indomethacin was significant (11.9% vs. 5.4%, P=0.018). Applying early precut success rate of biliary cannulation increased up to 98.1% and overall indomethacin diminished the frequency of PEP from 13.8% to 6.7% (P=0.007). Preventive effect of indomethacin was demonstrated in cases with defined procedure-related risk (28.3% vs. 13.8%, P=0.028) and with defined patient-related risk (16.3% vs. 7.0%, P=0.004), but not in patients without risk factors. CONCLUSIONS Rectally administered 100 mg indomethacin results in significantly lower PEP rate, particularly in cases with difficult cannulation and with identifiable patient-related or procedure-related risk factors.
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Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc 2015; 81:143-149.e9. [PMID: 25088919 DOI: 10.1016/j.gie.2014.06.045] [Citation(s) in RCA: 321] [Impact Index Per Article: 32.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/26/2013] [Accepted: 06/26/2014] [Indexed: 12/14/2022]
Abstract
BACKGROUND Data regarding the incidence and severity of post-ERCP pancreatitis (PEP) are primarily from nonrandomized studies. OBJECTIVE To determine the incidence, severity, and mortality of PEP from a systematic review of the placebo or no-stent arms of randomized, controlled trials (RCTs). DESIGN MEDLINE, EMBASE, and Cochrane databases were searched to identify RCTs evaluating the efficacy of drugs and/or pancreatic stents to prevent PEP. SETTING Systematic review of patients enrolled in RCTs evaluating agents for PEP prophylaxis. PATIENTS Patients in the placebo or no-stent arms of the RCTs INTERVENTION ERCP. MAIN OUTCOME MEASUREMENTS Incidence, severity, and mortality of PEP. RESULTS There were 108 RCTs with 13,296 patients in the placebo or no-stent arms. Overall, the PEP incidence was 9.7% and the mortality rate was 0.7%. Severity of PEP was reported for 8857 patients: 5.7%, 2.6%, and 0.5% of cases were mild, moderate, and severe, respectively. The incidence of PEP in 2345 high-risk patients was 14.7% and the severity of PEP was mild, moderate, and severe in 8.6%, 3.9%, and 0.8%, respectively, with a 0.2% mortality rate. The incidence of PEP was 13% in North American RCTs compared with 8.4% in European and 9.9% in Asian RCTs. ERCPs conducted before and after 2000 had a PEP incidence of 7.7% and 10%, respectively. LIMITATIONS Difference in PEP risk among patients in the included RCTs. CONCLUSION The incidence of PEP and severe PEP is similar in high-risk patients and the overall cohort. Discrepancies in the incidence of PEP across geographic regions require further study.
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Döbrönte Z, Szepes Z, Izbéki F, Gervain J, Lakatos L, Pécsi G, Ihász M, Lakner L, Toldy E, Czakó L. Is rectal indomethacin effective in preventing of post-endoscopic retrograde cholangiopancreatography pancreatitis? World J Gastroenterol 2014; 20:10151-10157. [PMID: 25110443 PMCID: PMC4123345 DOI: 10.3748/wjg.v20.i29.10151] [Citation(s) in RCA: 54] [Impact Index Per Article: 4.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/12/2014] [Revised: 03/12/2014] [Accepted: 04/21/2014] [Indexed: 02/06/2023] Open
Abstract
AIM To investigate the effectiveness of rectally administered indomethacin in the prophylaxis of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis and hyperamylasaemia in a multicentre study. METHODS A prospective, randomised, placebo-controlled multicentre study in five endoscopic units was conducted on 686 patients randomised to receive a suppository containing 100 mg indomethacin, or an inert placebo, 10-15 min before ERCP. Post-ERCP pancreatitis and hyperamylasaemia were evaluated 24 h following the procedure on the basis of clinical signs and laboratory parameters, and computed tomography/magnetic resonance imaging findings if required. RESULTS Twenty-one patients were excluded because of incompleteness of their data or because of protocol violation. The results of 665 investigations were evaluated: 347 in the indomethacin group and 318 in the placebo group. The distributions of the risk factors in the two groups did not differ significantly. Pancreatitis developed in 42 patients (6.3%): it was mild in 34 (5.1%) and severe in eight (1.2%) cases. Hyperamylaesemia occurred in 160 patients (24.1%). There was no significant difference between the indomethacin and placebo groups in the incidence of either post-ERCP pancreatitis (5.8% vs 6.9%) or hyperamylasaemia (23.3% vs 24.8%). Similarly, subgroup analysis did not reveal any significant differences between the two groups. CONCLUSION 100 mg rectal indomethacin administered before ERCP did not prove effective in preventing post-ERCP pancreatitis.
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The effect of indomethacin in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a meta-analysis. Pancreas 2014; 43:338-42. [PMID: 24622061 DOI: 10.1097/mpa.0000000000000086] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
OBJECTIVES Acute pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) is a severe complication with substantial morbidity and mortality. Indomethacin has been identified to prevent this complication; however, the results using indomethacin have varied. Therefore, we performed a meta-analysis on the efficacy of rectally administered indomethacin in the prevention of post-ERCP pancreatitis (PEP). METHODS A systematic search was performed in November 2012. Randomized, placebo-controlled trials (randomized controlled trials) in adult patients that compared rectally administered indomethacin versus placebo in prevention of PEP were included. Meta-analysis was performed using a fixed-effects model to assess the primary outcome (PEP) and secondary outcomes (mild or moderate to severe PEP) using Review Manager 5.1. RESULTS Four randomized controlled trials met the inclusion criteria (n = 1422). The use of indomethacin near the time of ERCP demonstrated a statistically significant decrease in PEP (odds ratio [OR], 0.49; 95% confidence interval [CI], 0.34-0.71; P < 0.01), mild PEP (OR, 0.52; 95% CI, 0.32-0.86; P = 0.01), and moderate to severe PEP (OR, 0.45; 95% CI, 0.24-0.83; P = 0.01) as compared with placebo. The number needed to treat with indomethacin to prevent 1 episode of pancreatitis is 17 patients. CONCLUSIONS Rectal indomethacin significantly reduced the incidence of PEP. We recommend using indomethacin before or just after the procedure in patients undergoing ERCP.
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Puig I, Calvet X, Baylina M, Isava Á, Sort P, Llaó J, Porta F, Vida F. How and when should NSAIDs be used for preventing post-ERCP pancreatitis? A systematic review and meta-analysis. PLoS One 2014; 9:e92922. [PMID: 24675922 PMCID: PMC3968039 DOI: 10.1371/journal.pone.0092922] [Citation(s) in RCA: 55] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/26/2013] [Accepted: 02/27/2014] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to be efficacious to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, the target patients, the type of NSAID, the route of administration and the time of drug delivery remain unclear, as well as the potential efficacy in reducing the severity of pancreatitis, length of hospital stay and mortality. The objective of the study was to evaluate these questions by performing a systematic review and meta-analysis. METHODS Multiple searches were performed in the main databases. Randomized controlled trials (RCTs) comparing NSAIDs vs. placebo in the prevention of post-ERCP pancreatitis were included. Primary endpoint of the study was the efficacy for pancreatitis prevention. Sub-analyses were performed to determine the risk reduction in high and low risk patients, and to define optimal time, route of administration, and type of NSAID. Secondary endpoints were safety, moderate to severe pancreatitis prevention and reduction of hospital stay and mortality. RESULTS Nine RCTs enrolling 2133 patients were included. The risk of pancreatitis was lower in the NSAID group than in the placebo group (RR 0.51; 95%CI 0.39-0.66). The number needed to treat was 14. The risk of moderate to severe pancreatitis was also lower in the NSAID group. (RR 0.46; 95%CI 0.28-0.76). No adverse events related to NSAID use were reported. NSAIDs were effective in both high-risk and unselected patients (RR 0.53; 95%CI 0.30-0.93 and RR 0.57; 95%CI 0.37-0.88). In the subanalyses, only rectal administration of either indomethacin (RR 0.54; 95%CI 0.38-0.75) or diclofenac (RR 0.42; 95%CI 0.21-0.84) was shown to be effective. There were not enough data to perform a meta-analysis in hospital stay reduction. No deaths occurred. CONCLUSION A single rectal dose of indomethacin or diclofenac before or immediately after ERCP is safe and prevents procedure-related pancreatitis both in high risk and in unselected patients.
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Affiliation(s)
- Ignasi Puig
- Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain
- Universitat Internacional de Catalunya, Barcelona, Spain
- Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain
- * E-mail:
| | - Xavier Calvet
- Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain
- Digestive Diseases Department, Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain
- Centro de Investigación Biomédica en Red de enfermedades hepáticas y digestivas (CIBERehd), Madrid, Spain
| | - Mireia Baylina
- Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain
- Internal Medicine Department, Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain
| | - Álvaro Isava
- Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain
- Universitat Internacional de Catalunya, Barcelona, Spain
| | - Pau Sort
- Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain
- Universitat Internacional de Catalunya, Barcelona, Spain
| | - Jordina Llaó
- Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain
- Universitat Internacional de Catalunya, Barcelona, Spain
| | - Francesc Porta
- Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain
- Universitat Internacional de Catalunya, Barcelona, Spain
| | - Francesc Vida
- Digestive Diseases Department, Althaia Xarxa Assistencial Universitària de Manresa, Barcelona, Spain
- Universitat Internacional de Catalunya, Barcelona, Spain
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Sun HL, Han B, Zhai HP, Cheng XH, Ma K. Rectal NSAIDs for the prevention of post-ERCP pancreatitis: a meta-analysis of randomized controlled trials. Surgeon 2013; 12:141-7. [PMID: 24332479 DOI: 10.1016/j.surge.2013.10.010] [Citation(s) in RCA: 52] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/24/2013] [Revised: 10/26/2013] [Accepted: 10/28/2013] [Indexed: 12/16/2022]
Abstract
BACKGROUND AND PURPOSE Acute pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP). We conducted a meta-analysis to evaluate the efficacy and safety of rectal nonsteroidal anti-inflammatory drugs (NSAIDs) for the prevention of post-ERCP pancreatitis (PEP). METHODS PubMed and Embase databases were searched through April 2013. Results are reported as relative risk (RR) or weighted mean difference (WMD) with 95% confidence interval (95% CI). The primary outcome measure was the incidence of PEP. Secondary outcome measures included the severity of PEP and serum amylase level 2 h, 24 h after ERCP. RESULTS Seven trials containing 1846 patients were eligible. Rectal NSAIDs significantly reduced the incidence of PEP (RR 0.45, 95% CI 0.34-0.61, P < 0.001). The results were maintained in subsequent subgroup analysis. Rectal NSAIDs also was associated with a reduction in the incidence of mild PEP (RR 0.54, 95% CI 0.35-0.83, P = 0.005), moderate to severe PEP (RR 0.39, 95% CI 0.22-0.70, P = 0.002), or serum amylase level 2 h after ERCP (WMD -91.09 IU/L, 95% CI -149.78 to -32.40, P = 0.002). CONCLUSIONS Rectal NSAIDs reduced the incidence and severity of PEP, as well as serum amylase level 2 h after ERCP.
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Affiliation(s)
- Hong-Li Sun
- Department of Biliary Vascular Surgery, Shenjing Hospital of China Medical University, Shenyang 110004, China
| | - Bing Han
- Department of Biliary Vascular Surgery, Shenjing Hospital of China Medical University, Shenyang 110004, China
| | - Hong-Peng Zhai
- Department of General Surgery, Central Hospital of Shenyang Medical College, Shenyang 110004, China
| | - Xin-Hua Cheng
- Department of Biliary Vascular Surgery, Shenjing Hospital of China Medical University, Shenyang 110004, China
| | - Kai Ma
- Department of Biliary Vascular Surgery, Shenjing Hospital of China Medical University, Shenyang 110004, China.
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Abstract
AIM: To compare the effects of new-type versus traditional non-steroid antiinflammtory drugs (NSAIDs) in the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP).
METHODS: One hundred and ninety-seven patients who underwent ERCP for choledocholithiasis between May 2012 and May 2013 were randomly divided into three groups: a lornoxicam group, a parecoxib group and a control group. Different drugs were applied for each group. Mean visual analogue score (VAS) and serum levels of amylase and C-reactive protein (CRP) were measured before ERCP and 4, 24 and 48 h after ERCP. Incidences of hyperamylasemia and PEP were observed.
RESULTS: The incidences of PEP in the lornoxicam group, parecoxib group and control group were 4.55%, 9.09% and 10.8%, respectively, and the difference was statistically significant between the parecoxib group and control group (P < 0.05), but not between the lornoxicam group and control group (P > 0.05). The incidences of post-ERCP hyperamylasemia in the parecoxib group and lornoxicam group were significantly lower than that in the control group (9.09%, 15.2% vs 21.5%, both P < 0.01). Serum CRP level at 4 h after ERCP was significantly lower in both treatment groups than in the control group (both P < 0.01). Mean VAS at 4 h after ERCP was significantly lower in both treatment groups than in the control group (both P < 0.01).
CONCLUSION: NSAIDs like lornoxicam and parecoxib can prevent the occurrence of hyperamylasemia induced by ERCP. Parecoxib could prevent the occurrence of PEP. Both drugs can alleviate pain and inflammatory reactions after the endoscopic procedure. As a new type of NSAIDs, selective cyclooxygenase-2 (COX-2) inhibitors might be more useful in preventing PEP.
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Akshintala VS, Hutfless SM, Colantuoni E, Kim KJ, Khashab MA, Li T, Elmunzer BJ, Puhan MA, Sinha A, Kamal A, Lennon AM, Okolo PI, Palakurthy MK, Kalloo AN, Singh VK. Systematic review with network meta-analysis: pharmacological prophylaxis against post-ERCP pancreatitis. Aliment Pharmacol Ther 2013; 38:1325-37. [PMID: 24138390 DOI: 10.1111/apt.12534] [Citation(s) in RCA: 46] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/07/2013] [Revised: 08/03/2013] [Accepted: 09/29/2013] [Indexed: 12/13/2022]
Abstract
BACKGROUND The efficacy of many pharmacological agents for preventing post-ERCP pancreatitis (PEP) has been evaluated in randomised controlled trials (RCTs), but it is unclear which agent(s) should be used in clinical practice. Network meta-analyses of RCTs are used to simultaneously compare several agents to determine their relative efficacy and identify priority agents for comparison in future RCTs. AIM To evaluate pharmacological agents for the prevention of PEP by conducting a network meta-analysis of RCTs. METHODS We searched MEDLINE, EMBASE and Cochrane Library databases for RCTs that evaluated the efficacy of agents for preventing PEP. RCTs were simultaneously analysed using random-effects network meta-analysis under the Bayesian framework to identify the best agents. The efficacy of agents was ordered according to the probability of being ranked as any of the top three best performing agents. RESULTS The network meta-analysis included 99 RCTs evaluating 16 agents in 25 313 patients. Topical epinephrine (adrenaline) was the most efficacious agent with 85.9% probability of ranking among the top three agents, followed by nafamostat (51.4%), antibiotics (44.5%) and NSAIDs (42.8%). However, in a sensitivity analysis including only rectal NSAIDs, NSAIDs moved from fourth rank to second (58.1%). Patients receiving topical epinephrine, compared with placebo, had a 75% reduced risk of PEP (OR 0.25, 95% probability interval 0.06-0.66). CONCLUSIONS Topical epinephrine and rectal NSAIDs are the most efficacious agents for preventing post-ERCP pancreatitis, based on existing RCTs. Combinations of these agents, which act on different steps in the pathogenesis of post-ERCP pancreatitis, should be evaluated in future trials.
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Affiliation(s)
- V S Akshintala
- Division of Gastroenterology, Johns Hopkins Medical Institutions, Baltimore, MD, USA
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Yaghoobi M, Rolland S, Waschke KA, McNabb-Baltar J, Martel M, Bijarchi R, Szego P, Barkun AN. Meta-analysis: rectal indomethacin for the prevention of post-ERCP pancreatitis. Aliment Pharmacol Ther 2013; 38:995-1001. [PMID: 24099466 DOI: 10.1111/apt.12488] [Citation(s) in RCA: 46] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/16/2013] [Revised: 07/22/2013] [Accepted: 08/25/2013] [Indexed: 12/18/2022]
Abstract
BACKGROUND Despite initial evidence in the literature, nonsteroidal anti-inflammatory drugs (NSAIDs) have not been widely used to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). AIM To complete a meta-analysis of high-quality RCTs that included the latest available literature published after past meta-analytical efforts METHODS A comprehensive electronic literature search was carried out for RCTs comparing peri-procedural rectal indomethacin and placebo in preventing PEP. Methodological quality was assessed by the Cochrane risk of bias tool. Fixed model Mantel-Haenszel meta-analysis, Q test and I(2) index were used. Several subgroup and sensitivity analyses were planned. RESULTS A total of four of 61 retrieved trials between 2007 and 2012 (n = 1470) were included. No significant publication bias existed. All studies used similar criteria to detect pancreatitis. The pooled proportion estimate of the rate of pancreatitis was 5.1% with indomethacin and 10.3% with placebo. After excluding the high-risk patients, the rates were 3.9% and 7.9% respectively. Fixed model meta-analysis showed that the rate of pancreatitis was significantly lower using indomethacin as compared with placebo [OR = 0.49(0.34-0.71); P = 0.0002]. Number needed to treat was 20. There was no significant statistical or clinical heterogeneity. In subgroup analysis, the difference remained unchanged for average-risk population [OR = 0.49(0.28-0.85); P = 0.01] or in preventing severe PEP [OR = 0.41(0.21-0.78); P = 0.007]. The result of the main outcome remained robust in multiple sensitivity analyses. CONCLUSIONS Rectal indomethacin used immediately before or after ERCP significantly reduces the risk of PEP to half in both low- and high-risk patients, and with both statistically and clinically significant conclusions. These results suggest that a possible change in routine practice for patients at both low and high risk of developing PEP should be advocated.
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Affiliation(s)
- M Yaghoobi
- Division of Gastroenterology, McGill University Health Sciences, Montreal, QC, Canada; Division of Gastroenterology, Jewish General Hospital, Montreal, QC, Canada; Division of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC, USA
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Jiang D, Lai MY, Chen JZ, Wei CH. Indomethacin for preventing post-endoscopic retrograde cholangiopancreatography pancreatitis: A meta-analysis. Shijie Huaren Xiaohua Zazhi 2013; 21:1343-1350. [DOI: 10.11569/wcjd.v21.i14.1343] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To assess the effectiveness and safety of indomethacin in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP).
METHODS: Electronic searches were conducted to retrieve randomized controlled trials (RCTs) comparing indomethacin to placebo in the prevention of PEP from the PubMed, Embase, CBM, CNKI, WANFANG and VIP databases. Data collection and literature evaluation were performed by two reviewers independently. Review Manager 5.0 was used for statistical analysis.
RESULTS: A total of 11 RCTs involving 2718 patients were included. The meta-analysis showed that indomethacin could reduce the incidence of PEP (OR = 0.39, 95%CI: 0.30-0.52, P < 0.00001) and hyperamylasemia (OR = 0.50, 95%CI: 0.37-0.67, P < 0.00001).
CONCLUSION: Indomethacin is safe and effective in reducing the incidence of PEP and hyperamylasemia.
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Gu WJ, Liu JC. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a complementary meta-analysis. Gastrointest Endosc 2013; 77:672-3. [PMID: 23498149 DOI: 10.1016/j.gie.2012.11.035] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/24/2012] [Accepted: 11/27/2012] [Indexed: 02/08/2023]
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Response to Drs Gu and Liu. Gastrointest Endosc 2013; 77:673-4. [PMID: 23498150 DOI: 10.1016/j.gie.2012.12.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2012] [Accepted: 12/05/2012] [Indexed: 02/08/2023]
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