|
1
|
Shahzil M, Chaudhary AJ, Qureshi AA, Hasan F, Faisal MS, Sohail A, Khaqan MA, Jamali T, Khan MZ, Alsheik E, Zuchelli T. Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Randomized Sham Controlled Trials. JGH Open 2024; 8:e70056. [PMID: 39605898 PMCID: PMC11599161 DOI: 10.1002/jgh3.70056] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/13/2024] [Revised: 09/13/2024] [Accepted: 11/11/2024] [Indexed: 11/29/2024]
Abstract
Introduction Gastroesophageal reflux disease (GERD) affects approximately 20% of adults in the United States. Proton pump inhibitors are the first-line treatment but are associated with long-term side effects. Endoscopic full-thickness plication (EFTP) is a minimally invasive alternative that improves the valvular mechanism of the gastroesophageal junction. This meta-analysis compared EFTP to a sham procedure for the treatment of refractory GERD. Materials and Methods This meta-analysis followed the Cochrane guidelines and PRISMA standards and was registered with PROSPERO (CRD42023485506). We searched MEDLINE, Embase, SCOPUS, and Cochrane Library through December 2023. Inclusion criteria targeted Randomized controlled trials comparing EFTP with sham procedures for GERD were included. Statistical analyses utilized RevMan with a random-effects model, and the results were considered significant at p < 0.05. Results Of the 2144 screened studies, three RCTs with 272 patients with GERD were included: 136 patients underwent EFTP and 136 underwent sham procedures. Primary outcomes showed a significant reduction in PPI usage (RR 0.51; 95% CI 0.35-0.73; p < 0.01) and more than 50% improvement in GERD-HRQL scores at 3 months (RR 15.81; 95% CI 1.40-178.71; p = 0.03). No significant difference was found in the DeMeester scores (MD: 12.57; 95% CI -35.12 to 9.98; p = 0.27). Secondary outcomes showed no significant difference in time with esophageal pH < 4, but a significant reduction in total reflux episodes. Conclusions EFTP significantly reduced PPI usage, improved GERD-HRQL scores, and decreased total reflux episodes compared with sham procedures, highlighting its potential as a minimally invasive treatment. Further research is needed to compare EFTP with other minimally invasive techniques to determine the most effective treatment option.
Collapse
Affiliation(s)
- Muhammad Shahzil
- Department of Internal MedicineWeiss Memorial Hospital LLCChicagoIllinoisUSA
| | | | | | - Fariha Hasan
- Department of Internal MedicineCooper University HospitalCamdenNew JerseyUSA
| | | | - Abdullah Sohail
- Department of Internal MedicineUniversity of Iowa Hospitals and ClinicsIowa CityIowaUSA
| | - Muhammad Ali Khaqan
- Department of Internal MedicineJohn H. Stroger, Jr. Hospital of Cook CountyChicagoIllinoisUSA
| | - Taher Jamali
- Department of GastroenterologyHenry Ford HospitalDetroitMichiganUSA
| | | | - Eva Alsheik
- Department of GastroenterologyHenry Ford HospitalDetroitMichiganUSA
| | - Tobias Zuchelli
- Department of GastroenterologyHenry Ford HospitalDetroitMichiganUSA
| |
Collapse
|
|
2
|
Harwani Y, Butala S, More B, Shukla V, Patel A. Endoscopic full-thickness plication along with argon plasma coagulation for treatment of proton pump inhibitor dependent gastroesophageal reflux disease. World J Gastrointest Endosc 2024; 16:250-258. [PMID: 38813575 PMCID: PMC11130550 DOI: 10.4253/wjge.v16.i5.250] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/13/2024] [Revised: 02/28/2024] [Accepted: 04/25/2024] [Indexed: 05/14/2024] Open
Abstract
BACKGROUND Most endoscopic anti-reflux interventions for gastroesophageal reflux disease (GERD) management are technically challenging to practice with inadequate data to support it utility. Therefore, this study was carried to evaluate the effectiveness and safety newer endoscopic full-thickness fundoplication (EFTP) device along with Argon Plasma Coagulation to treat individuals with GERD. AIM To evaluate the effectiveness and safety newer EFTP device along with Argon Plasma Coagulation to treat individuals with GERD. METHODS This study was a single-center comparative analysis conducted on patients treated at a Noble Institute of Gastroenterology, Ahmedabad, hospital between 2020 and 2022. The research aimed to retrospectively analyze patient data on GERD symptoms and proton pump inhibitor (PPI) dependence who underwent EFTP using the GERD-X system along with argon plasma coagulation (APC). The primary endpoint was the mean change in the total gastroesophageal reflux disease health-related quality of life (GERD-HRQL) score compared to the baseline measurement at the 3-month follow-up. Secondary endpoints encompassed enhancements in the overall GERD-HRQL score, improvements in GERD symptom scores at the 3 and changes in PPI usage at the 3 and 12-month time points. RESULTS In this study, patients most were in Hill Class II, and over half had ineffective esophageal motility. Following the EFTP procedure, there were significant improvements in heartburn and regurgitation scores, as well as GERD-HRQL scores (P < 0.001). PPI use significantly decreased, with 82.6% not needing PPIs or prokinetics at end of 1 year. No significant adverse events related to the procedures were observed in either group. CONCLUSION The EFTP along with APC procedure shows promise in addressing GERD symptoms and improving patients' quality of life, particularly for suitable candidates. Moreover, the application of a lone clip with APC yielded superior outcomes and exhibited greater cost-effectiveness.
Collapse
Affiliation(s)
- Yogesh Harwani
- Department of Gastroenterology, Nobel Gastro Hospital, Ahmedabad 408409, Gujarat, India
| | - Shreya Butala
- Department of Gastroenterology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow 226014, Uttar Pradesh, India
| | - Balaji More
- Department of Pharmacology, Mahatma Gandhi Medical College and Research Institute, Puducherry 607402, Puducherry, India
| | - Varun Shukla
- Department of Gastroenterology, Noble Institute of Gastroenterology, Ahmedabad 380009, Gujrat, India
| | - Anand Patel
- Department of Gastroenterology, Noble Institute of Gastroenterology, Ahmedabad 380009, Gujrat, India
| |
Collapse
|
|
3
|
Niu C, Zhang J, Iyer C, Saeed H, Zhu K, Elkhapery A, Okolo PI. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A systematic review and meta-analysis. Endosc Int Open 2024; 12:E199-E210. [PMID: 38390496 PMCID: PMC10883465 DOI: 10.1055/a-2231-7136] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/10/2023] [Accepted: 12/13/2023] [Indexed: 02/24/2024] Open
Abstract
Background and study aims Gastroesophageal reflux disease (GERD) is a widespread chronic gastrointestinal condition with an increasing worldwide prevalence. This research was a systematic review and meta-analysis evaluating the efficacy, safety, and long-term outcomes of endoscopic full-thickness plication (EFTP) for the treatment of GERD. Methods A comprehensive search of databases was conducted for studies published up to April 2023. We included randomized controlled trials (RCTs) and prospective observational studies that examined the use of EFTP in treating GERD among adult patients. We calculated pooled effect estimates using a random-effects model. Results EFTP significantly improved GERD Health-Related Quality of Life (GERD-HRQL) scores at 3-, 6-, and 12-month follow-up intervals. A considerable proportion of patients discontinued proton pump inhibitors, with cessation rates of 59% (95% confidence interval [CI]: 0.47-0.71), 68% (95% CI: 0.58-0.78), and 67% (95% CI: 0.46-0.89,) at 3, 6, and 12 months, respectively. At 3 and 6 months, 61% (95% CI: 0.54-0.68) and 66% (95% CI: 0.56-0.76) of patients experienced ≥50% improvement in GERD-HRQL scores. EFTP demonstrated a favorable safety profile, with a low rate of severe adverse events. We observed a 6.76% reduction (95% CI: -14.53-1.02) in the percentage of time with esophageal pH <4, a decrease in DeMeester scores, and fewer total reflux episodes. The average procedure time was 22.75 minutes (95% CI: 22.03-23.48). Subgroup analyses suggest that both the GERDx system and the NDO Plicator are effective and safe in treating GERD. Conclusions The findings from our study reveal that EFTP is a safe and effective treatment for GERD patients who have not responded adequately to conventional therapies. Given its minimally invasive nature, effectiveness, and limited adverse effects, EFTP emerges as a compelling alternative to conventional surgical procedures.
Collapse
Affiliation(s)
- Chengu Niu
- Internal medicine, Rochester General Hospital, Rochester, United States
| | - Jing Zhang
- Internal medicine, Harbin Medical University, Harbin, China
| | - Charoo Iyer
- Internal medicine, Rochester General Hospital, Rochester, United States
| | - Hasaan Saeed
- Internal medicine, Rochester General Hospital, Rochester, United States
| | - Kaiwen Zhu
- Internal medicine, Rochester General Hospital, Rochester, United States
| | - Ahmed Elkhapery
- Internal medicine, Rochester General Hospital, Rochester, United States
| | - Patrick I Okolo
- Internal medicine, Rochester General Hospital, Rochester, United States
| |
Collapse
|
|
4
|
Maydeo A, Patil G, Kamat N, Dalal A, Vadgaonkar A, Parekh S, Daftary R, Vora S. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux after peroral endoscopic myotomy: a randomized sham-controlled study. Endoscopy 2023; 55:689-698. [PMID: 36944359 PMCID: PMC10374353 DOI: 10.1055/a-2040-4042] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2022] [Accepted: 02/01/2023] [Indexed: 03/23/2023]
Abstract
BACKGROUND : Endoscopic full-thickness plication (EFTP) has shown promising results in gastroesophageal reflux disease (GERD), but its efficacy in GERD after peroral endoscopic myotomy (POEM) is unclear. METHODS : In a prospective, randomized trial of post-POEM patients dependent on proton pump inhibitors (PPIs) for documented GERD, patients underwent EFTP (plication to remodel the gastroesophageal flap valve) or an endoscopic sham procedure (positioning of the EFTP device, but no stapling). The primary end point was improvement in acid exposure time (AET) < 6 % (3 months). Secondary end points included improvement in esophagitis (3 months), GERD Questionnaire (GERDQ) score (3 and 6 months), and PPI usage (6 months). RESULTS : 60 patients were randomized (30 in each group). At 3 months, a significantly higher proportion of patients achieved improvement in AET < 6 % in the EFTP group compared with the sham group (69.0 % [95 %CI 52.1-85.8] vs. 10.3 % [95 %CI 0-21.4], respectively). EFTP was statistically superior to sham (within-group analysis) in improving esophageal AET, DeMeester Score, and all reflux episodes (P < 0.001). A nonsignificant improvement in esophagitis was noted in the EFTP group (P = 0.14). Median GERDQ scores (3 months) were significantly better (P < 0.001) in the EFTP group, and the same trend continued at 6 months. A higher proportion of patients in the sham group continued to use PPIs (72.4 % [95 %CI 56.1-88.7] vs. 27.6 % [95 %CI 11.3-43.8]). There were no major adverse events in either group. CONCLUSION : EFTP improved post-POEM GERD symptoms, 24-hour pH impedance findings with normalization in one-third, and reduced PPI usage at 6 months.
Collapse
Affiliation(s)
- Amit Maydeo
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Gaurav Patil
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Nagesh Kamat
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Ankit Dalal
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Amol Vadgaonkar
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Sanil Parekh
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Rajen Daftary
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| | - Sehajad Vora
- Baldota Institute of Digestive Sciences, Gleneagles Global Hospital, Mumbai, Maharashtra, India
| |
Collapse
|
|
5
|
Kalapala R, Singla N, Reddy DN. Endoscopic management of gastroesophageal reflux disease: Panacea for proton pump inhibitors dependent/refractory patients. Dig Endosc 2022; 34:687-699. [PMID: 34651353 DOI: 10.1111/den.14169] [Citation(s) in RCA: 9] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/29/2021] [Revised: 10/06/2021] [Accepted: 10/12/2021] [Indexed: 02/08/2023]
Abstract
Endoscopic therapies in proton pump inhibitors (PPI) dependent/refractory gastroesophageal reflux disease (GERD) are increasingly indicated in patients who are not suitable or willing for chronic medical therapy and surgical fundoplication. Currently available endoluminal anti-reflux procedures include radiofrequency therapy (Stretta), suturing/plication and mucosal ablation/resection techniques at the gastroesophageal junction. Meticulous work up and patient selection results in a favorable outcome with these endoscopic therapies, especially the quality of life and partially the PPI independence. Stretta can be considered in patients with PPI refractory GERD and might have a role in patients with reflux hypersensitivity and functional heartburn. Endoscopic fundoplication using the Esophyx device and the GERD-X device have strong evidence (multiple randomized controlled trials) in patients with small hiatus hernia and high volume reflux episodes. Mucosal resection/ablation techniques like anti-reflux mucosectomy and anti-reflux mucosal ablation have shown promising results but need long term follow-up studies to prove their efficacy. The subset of PPI dependent GERD population will benefit from endoscopic therapies and the future of endoscopic management of GERD looks promising.
Collapse
Affiliation(s)
| | - Neeraj Singla
- Asian Institute of Gastroenterology, Hyderabad, India
| | | |
Collapse
|
|
6
|
Gong EJ, Park CH, Jung DH, Kang SH, Lee JY, Lim H, Kim DH. Efficacy of Endoscopic and Surgical Treatments for Gastroesophageal Reflux Disease: A Systematic Review and Network Meta-Analysis. J Pers Med 2022; 12:jpm12040621. [PMID: 35455737 PMCID: PMC9031147 DOI: 10.3390/jpm12040621] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2022] [Revised: 04/06/2022] [Accepted: 04/08/2022] [Indexed: 02/04/2023] Open
Abstract
Although various endoscopic and surgical procedures are available for the treatment of gastroesophageal reflux disease (GERD), the comparative efficacy of these treatments has not been fully elucidated. This study aimed to comprehensively evaluate the efficacy of various endoscopic and surgical treatments for GERD. All relevant randomized controlled trials published through August 2021 that compared the efficacy of endoscopic and surgical GERD treatments, including radiofrequency energy delivery, endoscopic plication, reinforcement of the lower esophageal sphincter (LES), and surgical fundoplication, were searched. A network meta-analysis was performed to analyze treatment outcomes, including the requirement of proton pump inhibitor (PPI) continuation and GERD-health-related quality of life questionnaire score (GERD-HRQL). As such, 25 studies with 2854 patients were included in the analysis. Endoscopic plication, reinforcement of the LES, and surgical fundoplication were effective in reducing the requirement of PPI continuation compared to PPI therapy (pooled risk ratio (RR) (95% confidence interval [CI]): endoscopic plication, 0.34 (0.21–0.56); reinforcement of LES, 0.32 (0.16–0.63), and surgical fundoplication, 0.16 (0.06–0.42)). Radiofrequency energy delivery tended to reduce the requirement of PPI continuation compared to PPI therapy (RR (95% CI): 0.55 (0.25–1.18)). In terms of GERD-HRQL, all endoscopic and surgical treatments were superior to PPI therapy. In conclusion, all endoscopic or surgical treatments, except radiofrequency energy delivery, were effective for discontinuation of PPI medication, especially surgical fundoplication. Quality of life, measured by GERD-HRQL, also improved in patients who underwent endoscopic or surgical treatment compared to those who received PPI therapy.
Collapse
Affiliation(s)
- Eun Jeong Gong
- Department of Internal Medicine, Hallym University College of Medicine, Chuncheon 24253, Korea;
| | - Chan Hyuk Park
- Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, Korea;
| | - Da Hyun Jung
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea;
| | - Sun Hyung Kang
- Department of Internal Medicine, Chungnam National University School of Medicine, Daejeon 35015, Korea;
| | - Ju Yup Lee
- Department of Internal Medicine, Keimyung University School of Medicine, Daegu 42601, Korea;
| | - Hyun Lim
- Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang 14068, Korea;
| | - Do Hoon Kim
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, Korea
- Correspondence: ; Tel.: +82-2-3010-3193
| | | |
Collapse
|
|
7
|
Kalapala R, Karyampudi A, Nabi Z, Darisetty S, Jagtap N, Ramchandani M, Gupta R, Lakhtakia S, Goud R, Venkat Rao G, Sharma P, Reddy DN. Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial. Gut 2022; 71:686-694. [PMID: 33849942 PMCID: PMC8921577 DOI: 10.1136/gutjnl-2020-321811] [Citation(s) in RCA: 22] [Impact Index Per Article: 7.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/13/2020] [Revised: 03/30/2021] [Accepted: 04/01/2021] [Indexed: 12/17/2022]
Abstract
BACKGROUND The majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD. DESIGN Patients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months. RESULTS Seventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29-42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001) and 12 (92.3 (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group. CONCLUSION EFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate. TRIAL REGISTRATION NUMBER NCT03322553.
Collapse
Affiliation(s)
- Rakesh Kalapala
- Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - Arun Karyampudi
- Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - Zaheer Nabi
- Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - Santosh Darisetty
- Anaesthesia, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - Nitin Jagtap
- Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India
| | - Mohan Ramchandani
- Gastroenterology, Asian Institute of Gastroenetrology, Hyderabad, Andhra Pradesh, India
| | - Rajesh Gupta
- Asian Institute of Gatroenterology, Hyderabad, India
| | - Sundeep Lakhtakia
- Gastroenterology, Asian Institute of Gastroenetrology, Hyderabad, Andhra Pradesh, India
| | - Rajesh Goud
- Asian Institute of Gastroenterology, Hyderabad, Telangana, India
| | - G Venkat Rao
- Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India
| | | | - D Nageshwar Reddy
- Asian Healthcare Foundation, Asian Institute of Gastroenterology, Hyderabad, Andhra Pradesh, India
| |
Collapse
|
|
8
|
Kushner BS, Awad MM, Mikami DJ, Chand BB, Wai CJ, Murayama KM. Endoscopic treatments for GERD. Ann N Y Acad Sci 2020; 1482:121-129. [PMID: 33063344 DOI: 10.1111/nyas.14511] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/12/2020] [Revised: 09/18/2020] [Accepted: 09/22/2020] [Indexed: 12/11/2022]
Abstract
Gastroesophageal reflux disease (GERD) is a condition with increasing prevalence and morbidity in the United States and worldwide. Despite advances in medical and surgical therapy over the last 30 years, gaps remain in the therapeutic profile of options. Flexible upper endoscopy offers the promise of filling in these gaps in a potentially minimally invasive approach. In this concise review, we focus on the plethora of endoluminal therapies available for the treatment of GERD. Therapies discussed include injectable agents, electrical stimulation of the lower esophageal sphincter, antireflux mucosectomy, radiofrequency ablation, and endoscopic suturing devices designed to create a fundoplication. As new endoscopic treatments become available, we come closer to the promise of the incisionless treatment of GERD. The known data surrounding the indications, benefits, and risks of these historical, current, and emerging approaches are reviewed in detail.
Collapse
Affiliation(s)
- Bradley S Kushner
- Department of Surgery, Washington University School of Medicine, Washington University in St. Louis, St. Louis, Missouri
| | - Michael M Awad
- Department of Surgery, Washington University School of Medicine, Washington University in St. Louis, St. Louis, Missouri
| | - Dean J Mikami
- Department of Surgery, John A. Burns School of Medicine, University of Hawaii, Honolulu, Hawaii
| | - Bipan B Chand
- Department of Surgery, Stritch School of Medicine, Loyola University Chicago, Chicago, Illinois
| | - Christina J Wai
- Department of Surgery, John A. Burns School of Medicine, University of Hawaii, Honolulu, Hawaii
| | - Kenric M Murayama
- Department of Surgery, John A. Burns School of Medicine, University of Hawaii, Honolulu, Hawaii
| |
Collapse
|
|
9
|
Vaezi MF, Shaheen NJ, Muthusamy VR. State of Evidence in Minimally Invasive Management of Gastroesophageal Reflux: Findings of a Scoping Review. Gastroenterology 2020; 159:1504-1525. [PMID: 32621903 DOI: 10.1053/j.gastro.2020.05.097] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/28/2020] [Revised: 04/30/2020] [Accepted: 05/11/2020] [Indexed: 12/13/2022]
Abstract
BACKGROUNDS & AIMS Endoscopic management of gastroesophageal reflux disease (GERD) is being employed increasingly. The aim of this scoping review was to assess the volume of available evidence on the benefits of endoscopic and minimally invasive surgical therapies for GERD. METHODS criteria were used to perform an extensive literature search of data regarding the reported benefit of endoscopic therapies in GERD. Randomized controlled studies were utilized when available; however, data from observational studies were also reviewed. RESULTS A formal review of evidence was performed in 22 studies. Inclusion and exclusion criteria and study duration were noted and tabulated. Assessment of outcomes was based on symptoms and objective criteria reported by investigators. Reported outcomes for the interventions were tabulated under the heading of subjective (symptom scores, quality of life metrics, and change in proton pump inhibitor use) and objective metrics (pH parameters, endoscopic signs, and lower esophageal sphincter pressure changes). Adverse events were noted and tabulated. The majority of studies showed symptomatic and objective improvement of GERD with the device therapies. Adverse events were minimal. However, normalization of acid exposure occurred in about 50% of patients and, for some modalities, long-term durability is uncertain. CONCLUSIONS This scoping review revealed that the endoluminal and minimally invasive surgical devices for GERD therapy are a promising alternative to proton pump inhibitor therapy. Their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially durability of effect, are better understood.
Collapse
Affiliation(s)
- Michael F Vaezi
- Division of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee.
| | - Nicholas J Shaheen
- Division of Gastroenterology, Hepatology, and Nutrition, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - V Raman Muthusamy
- Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California
| |
Collapse
|
|
10
|
Coronel MA, Bernardo WM, Moura DTHD, Moura ETHD, Ribeiro IB, Moura EGHD. THE EFFICACY OF THE DIFFERENT ENDOSCOPIC TREATMENTS VERSUS SHAM, PHARMACOLOGIC OR SURGICAL METHODS FOR CHRONIC GASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS. ARQUIVOS DE GASTROENTEROLOGIA 2018; 55:296-305. [PMID: 30540095 DOI: 10.1590/s0004-2803.201800000-65] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/12/2018] [Accepted: 05/14/2018] [Indexed: 12/15/2022]
Abstract
BACKGROUND Endoscopic antireflux treatments for gastroesophageal reflux disease (GERD) are still evolving, and most of the published studies address symptom relief in the short-term. Objective - We aimed to perform a systematic review and meta-analysis focused on evaluating the efficacy of the different endoscopic procedures. METHODS Search was restricted to randomized controlled trials (RCTs) on MedLine, Cochrane, SciELO, and EMBASE for patients with chronic GERD (>6 months), over 18 years old and available follow up of at least 3 months. The main outcome was to evaluate the efficacy of the different endoscopic treatments compared to sham, pharmacological or surgical treatment. Efficacy was measured by different subjective and objective outcomes. RESULTS We analyzed data from 16 RCT, totaling 1085 patients. The efficacy of endoscopic treatments compared to sham and proton pump inhibitors (PPIs) treatment showed a significant difference up to 6 months in favor of endoscopy with no heterogeneity (P<0.00001) (I2: 0%). The subgroup analysis showed a statistically significant difference up to 6 months in favor of endoscopy: endoscopy vs PPI (P<0.00001) (I2: 39%). Endoscopy vs sham (P<0.00001) (I2: 0%). Most subjective and objective outcomes were statistically significant in favor of endoscopy up to 6 and 12 months follow up. CONCLUSION This systematic review and meta-analysis shows a good short-term efficacy in favor of endoscopic procedures when comparing them to a sham and pharmacological or surgical treatment. Data on long-term follow up is lacking and this should be explored in future studies.
Collapse
Affiliation(s)
- Martin Andrés Coronel
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Wanderley Marques Bernardo
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Diogo Turiani Hourneaux de Moura
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Eduardo Turiani Hourneaux de Moura
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Igor Braga Ribeiro
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| | - Eduardo Guimarães Hourneaux de Moura
- Universidade de São Paulo, Faculdade de Medicina, Hospital das Clínicas, Departamento de Endoscopia Avançada Gastrointestinal, São Paulo, SP, Brasil
| |
Collapse
|
|
11
|
De Moura EGH, Sallum RAA, Nasi A, Coronel M, De Moura DTH, De Moura ETH, Minata MK, Cury M, Falcão A, Cecconello I, Sakai P. Endoscopic polymer injection and endoluminal plication in treatment of gastroesophageal reflux disease: evaluation of long-term results. Endosc Int Open 2018; 6:E630-E636. [PMID: 29756023 PMCID: PMC5943693 DOI: 10.1055/a-0573-1194] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/31/2017] [Accepted: 01/03/2018] [Indexed: 12/11/2022] Open
Abstract
BACKGROUND AND STUDY AIMS Us of proton pump inhibitors (PPIs) has made endoscopic treatment of gastroesophageal reflux disease (GERD) more efficient, with reduction in morbidity and complications. However, some patients persist with symptoms despite medical treatment and some are not compliant with it or cannot afford it for financial reasons, and thus they require non-pharmacological therapeutic options such as surgical fundoplication. Surgery may be effective in the short term, but there is related morbidity and concern about its long-term efficacy. The possibility of minimally invasive endoluminal surgeries has resulted in interest in and development of newly endoscopic devices. Good short-term results with surgical fundoplication lack of studies of is with long follow-up justify our interest in this study. The aim of this study was to investigate the efficacy of endoscopic polymer injection and endoluminal full-thickness plication in the long-term control of GERD. PATIENTS AND METHODS Forty-seven patients with GERD who underwent an endoscopic procedure were followed up for 60 months and evaluated for total response (RT), partial response (RP) and no response (SR) to endoscopic treatment with reintroduction of PPIs. RESULTS Twenty-one patients received polymer injection (G0) and 26 endoluminal plication (G1). The number of patients with no response to endoscopic treatment with reintroduction of PPIs increased in time for both techniques (G0 P = 0.006; G1 P < 0.001). There was symptomatic improvement up to 12 months, with progressive loss of this trending up to 60 months in G0 and G1 ( P < 0.001). Health-related quality of life score (GERD-HRQL) demonstrated TR in G0 and G1 at 1, 3, 6 and 12 months. The 60-month analysis showed an increased number of patients with SR in both groups. The quality of life assessment (SF-36) showed benefit in G0 up to 3 months. G0 showed a higher rate of complications. There were no deaths. There was healing of esophagitis at 3 months in 45 % of patients in G0 and 40 % in G1. There was no improvement in manometric or pH findings. CONCLUSION Endoscopic therapies were ineffective in controlling GERD in the long term.
Collapse
Affiliation(s)
| | - Rubens A. A. Sallum
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Ary Nasi
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Martin Coronel
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil,Corresponding author Martin Coronel Universidade de São Paulo Faculdade de MedicinaGastrointestinal EndoscopyAv. Dr Enéas de Carvalho Aguiar 225
6
o
andar, bloco 3
Cerqueira Cezar ZIP Code 05403-010São Paulo, SP, Brazil+55-112-661-6467
| | - Diogo Turiani Hourneaux De Moura
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | | | - Mauricio Kazuyoshi Minata
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Marcelo Cury
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Angela Falcão
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Ivan Cecconello
- Gastrointestinal Surgical Department, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| | - Paulo Sakai
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brazil
| |
Collapse
|
|
12
|
Long-term outcomes of cruroplasty reinforcement with composite versus biologic mesh for gastroesophageal reflux disease. Surg Endosc 2015; 30:2865-72. [DOI: 10.1007/s00464-015-4570-6] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/26/2015] [Accepted: 09/15/2015] [Indexed: 12/13/2022]
|
|
13
|
Locke GR, Horwhat J, Mashimo H, Savarino E, Zentilin P, Savarino V, Zerbib F, Armbruster SP, Wong RK, Moawad F. Endotherapy for and tailored approaches to treating GERD, and refractory GERD. Ann N Y Acad Sci 2013; 1300:166-186. [PMID: 24117641 DOI: 10.1111/nyas.12240] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
This paper presents commentaries on how endoluminal antireflux procedures compare to laparoscopic fundoplication; new endoscopic procedures being studied to treat refractory gastroesophageal reflux disease (GERD); the new Stretta; the relationship between obesity and proton pump inhibitor (PPI) resistance; data concerning acid hypersensitivity and sensory receptors (vallinoid, TRPV1) causing refractory GERD; whether microscopic esophagitis is relevant in determining symptoms of non-erosive reflux disease (NERD); how concomitant functional gastrointestinal disorders affect the PPI response in NERD; the evidence that a functional esophagus is associated with inflammatory bowel syndrome (IBS); the role of GABA agonists in the treatment of refractory GERD; the role of biofeedback and antidepressants in refractory GERD; and endoluminal fundoplication using the EsophyX device.
Collapse
Affiliation(s)
- G Richard Locke
- Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota
| | - John Horwhat
- Department of Medicine, Walter Reed National Military Medical Center, Bethesda, Maryland
| | - Hiroshi Mashimo
- VA Boston Healthcare System/Harvard Medical School, Boston, Massachusetts
| | - Edoardo Savarino
- Department of Surgical, Oncological and Gastroenterological Sciences, University of Padua, Padua, Italy
| | | | | | - Frank Zerbib
- Department of Gastroenterology, CHU Bordeaux, Saint Andre Hospital, Bordeaux, France
| | - Steven P Armbruster
- Department of Gastroenterology, Walter Reed National Military Medical Center, Bethesda, Maryland
| | - Roy K Wong
- Department of Gastroenterology, Walter Reed National Military Medical Center, Bethesda, Maryland
| | - Fouad Moawad
- Department of Gastroenterology, Walter Reed National Military Medical Center, Bethesda, Maryland
| |
Collapse
|
|
14
|
Zhang W, Tang W, Shan CX, Liu S, Jiang ZG, Jiang DZ, Zheng XM, Qiu M. Dual-sided composite mesh repair of hiatal hernia: Our experience and a review of the Chinese literature. World J Gastroenterol 2013; 19:5528-5533. [PMID: 24023497 PMCID: PMC3761107 DOI: 10.3748/wjg.v19.i33.5528] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/27/2013] [Revised: 05/06/2013] [Accepted: 07/05/2013] [Indexed: 02/06/2023] Open
Abstract
AIM: To summarize our experience in the application of Crurasoft® for antireflux surgery and hiatal hernia (HH) repair and to introduce the work of Chinese doctors on this topic.
METHODS: Twenty-one patients underwent HH repair with Crurasoft® reinforcement. Gastroesophageal reflux disease (GERD) and HH-related symptoms including heartburn, regurgitation, chest pain, dysphagia, and abdominal pain were evaluated preoperatively and 6 mo postoperatively. A patient survey was conducted by phone by one of the authors. Patients were asked about “recurrent reflux or heartburn” and “dysphagia”. An internet-based Chinese literature search in this field was also performed. Data extracted from each study included: number of patients treated, hernia size, hiatorrhaphy, antireflux surgery, follow-up period, recurrence rate, and complications (especially dysphagia).
RESULTS: There were 8 type I, 10 type II and 3 type III HHs in this group. Mean operative time was 119.29 min (range 80-175 min). Intraoperatively, length and width of the hiatal orifice were measured, (4.33 ± 0.84 and 2.85 ± 0.85 cm, respectively). Thirteen and eight Nissen and Toupet fundoplications were performed, respectively. The intraoperative complication rate was 9.52%. Despite dysphagia, GERD-related symptoms improved significantly compared with those before surgery. The recurrence rate was 0% during the 6-mo follow-up period, and long-term follow-up disclosed a recurrence rate of 4.76% with a mean period of 16.28 mo. Eight patients developed new-onset dysphagia. The Chinese literature review identified 12 papers with 213 patients. The overall recurrence rate was 1.88%. There was no esophageal erosion and the rate of dysphagia ranged from 0% to 24%.
CONCLUSION: The use of Crurasoft® mesh for HH repair results in satisfactory symptom control with a low recurrence rate. Postoperative dysphagia continues to be an issue, and requires more research to reduce its incidence.
Collapse
|
|
15
|
Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GERD by using multiple plication implants. Gastrointest Endosc 2013; 77:7-14. [PMID: 23021166 DOI: 10.1016/j.gie.2012.07.033] [Citation(s) in RCA: 34] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/16/2012] [Accepted: 07/19/2012] [Indexed: 02/08/2023]
Abstract
BACKGROUND Subjective and especially objective data after endoluminal full-thickness gastroplication are scarce. OBJECTIVE To evaluate symptoms and reflux activity 12 months after gastroplication by using multichannel intraluminal impedance monitoring. DESIGN Open-label, prospective, single-center study. SETTING Tertiary referral hospital in Zell am See, Austria. PATIENTS Subjects without hiatal hernias with documented GERD and persistent or recurrent symptoms despite treatment with a proton pump inhibitor. INTERVENTIONS A total of 36 patients underwent endoscopic full-thickness gastroplication with 1 or more Plicator implants. MAIN OUTCOME MEASUREMENTS Mean Gastrointestinal Quality of Life Index and reflux-specific symptom scores significantly improved on follow-up (P < .01). Atypical reflux, gas/bloating, and bowel dysfunction-specific symptom scores as well as belching and dysphagia scores improved. Twenty-two patients returned for esophageal manometry and multichannel intraluminal impedance testing 1 year after surgery. DeMeester scores decreased from 20 to 10 (P < .029). The median numbers of total, acid, proximal, upright, and recumbent reflux episodes were all significantly reduced (P < .05). Manometric data were virtually unchanged. The percentage of patients taking proton pump inhibitors on daily basis after the procedure was 11.5%. There was only 1 postprocedure incident (bleeding) that required intervention. Three of 36 patients (8.3%) were considered treatment failures because of persistent symptoms and were assigned to undergo laparoscopic fundoplication. LIMITATIONS No randomized comparison with a sham procedure or laparoscopic fundoplication; follow-up interval. CONCLUSIONS Endoscopic plication is safe and improves objective and subjective parameters at 1-year follow-up, without side effects seen after laparoscopic fundoplication. Further studies on the clinical merit of this procedure in specific patient populations are warranted.
Collapse
|
|
16
|
Louis H. Endoscopic full-thickness plication for the treatment of GERD: is there a future? Gastrointest Endosc 2013; 77:15-7. [PMID: 23261091 DOI: 10.1016/j.gie.2012.09.009] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2012] [Accepted: 09/12/2012] [Indexed: 02/08/2023]
|