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Shin J, Cha B, Hong J, Kwon KS, Lee E, Maeng JH, Chung JW, Park DK, Kim YJ, Kwon KA, Kim JH, Seo KS, Hong SJ, Kim KO. Prevention of rebleeding after primary haemostasis using haemostatic powder in non-variceal upper gastrointestinal bleeding: a multicentre randomised controlled trial. Gut 2025:gutjnl-2024-332459. [PMID: 40360231 DOI: 10.1136/gutjnl-2024-332459] [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: 03/20/2024] [Accepted: 05/01/2025] [Indexed: 05/15/2025]
Abstract
BACKGROUND Non-variceal upper gastrointestinal bleeding (NVUGIB) remains a major cause of morbidity and mortality. Rebleeding rates following endoscopic treatment can reach up to 25% within 72 hours in patients with high-risk lesions. OBJECTIVE To evaluate the efficacy of a haemostatic powder (Nexpowder) in reducing rebleeding rates after conventional endoscopic treatment in patients with NVUGIB. DESIGN This was a prospective, multicentre, randomised controlled trial involving patients with acute NVUGIB from high-risk lesions who achieved initial endoscopic haemostasis. Participants were randomised 1:1 to receive either the haemostatic powder or no further therapy (control group). The primary outcome was the rebleeding rate within 72 hours post-treatment. Secondary outcomes included the 30-day rebleeding rate and the safety profile. RESULTS A total of 341 patients (72.1% male; mean age 64.8 years) were included, with 173 in the powder group and 168 in the control group. Baseline characteristics were similar between groups. Ulcer bleeding was the predominant aetiology (n=317), with Forrest type I bleeding observed in two-thirds of cases. The 72-hour rebleeding rate was significantly lower in the powder group (2.9%, 95% CI 0.9 to 6.6%) compared with the control group (11.3%, 95% CI 6.9 to 17.1%; p =0.005). A significant reduction was also observed in the 30-day cumulative rebleeding rate (7.0% vs 18.8%), with similar findings in the ulcer subgroup for the 3-day rebleeding rate (3.0% vs 12.0%; p =0.004). No adverse events related to the powder application were reported. CONCLUSION The application of Nexpowder following endoscopic haemostasis significantly reduced both early (3 days) and late (30 days) rebleeding rates in patients with NVUGIB, particularly in cases of ulcer-related bleeding. TRIAL REGISTRATION NUMBER NCT04124588.
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Affiliation(s)
- Jongbeom Shin
- Department of Internal Medicine, Inha University Hospital, Inha University, Incheon, Korea (the Republic of)
| | - Boram Cha
- Department of Internal Medicine, Inha University Hospital, Inha University, Incheon, Korea (the Republic of)
| | - Jitaek Hong
- Department of Internal Medicine, Inha University Hospital, Inha University, Incheon, Korea (the Republic of)
| | - Kye Sook Kwon
- Department of Internal Medicine, Inha University Hospital, Inha University, Incheon, Korea (the Republic of)
| | - Eunhye Lee
- Utah-Inha DDS & Advanced Therapeutics Research Center, Incheon, Korea (the Republic of)
| | - Jin Hee Maeng
- Utah-Inha DDS & Advanced Therapeutics Research Center, Incheon, Korea (the Republic of)
| | - Jun-Won Chung
- Department of Internal Medicine, Gachon University College of Medicine, Gachon University Gil Medical Center, Incheon, Korea (the Republic of)
| | - Dong Kyun Park
- Department of Internal Medicine, Gachon University College of Medicine, Gachon University Gil Medical Center, Incheon, Korea (the Republic of)
| | - Yoon Jae Kim
- Department of Internal Medicine, Gachon University College of Medicine, Gachon University Gil Medical Center, Incheon, Korea (the Republic of)
| | - Kwang An Kwon
- Department of Internal Medicine, Gachon University College of Medicine, Gachon University Gil Medical Center, Incheon, Korea (the Republic of)
| | - Jung Ho Kim
- Department of Internal Medicine, Gachon University College of Medicine, Gachon University Gil Medical Center, Incheon, Korea (the Republic of)
| | - Kwang-Suk Seo
- Department of Dental Anesthesiology, School of Dentistry, Seoul National University, Seoul, Korea (the Republic of)
| | - Su Jin Hong
- Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea (the Republic of)
| | - Kyoung Oh Kim
- Department of Internal Medicine, Gachon University College of Medicine, Gachon University Gil Medical Center, Incheon, Korea (the Republic of)
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Li H, Zuo J, Wang W, Wu S, Zhao Y, Wei Y, Song J, Zhang Z, Yao W, Wang J, Liu C, Wei H, Liang Z, Yang X, Yang K, Lv F, Wang Y, Li P, Zhang S. Efficacy of Polysaccharide Hemostatic Powder on Blood Oozing Among Patients With Postendoscopic Sphincterotomy Bleeding: A Randomized Controlled Trial. Am J Gastroenterol 2025:00000434-990000000-01683. [PMID: 40192133 DOI: 10.14309/ajg.0000000000003468] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/19/2025] [Accepted: 03/26/2025] [Indexed: 05/11/2025]
Abstract
INTRODUCTION Postendoscopic sphincterotomy (EST) bleeding presents challenges for endoscopists using side-viewing duodenoscopes. Recently, polysaccharide hemostatic powder (PHP) has shown promising results in managing gastrointestinal hemorrhage. Given the established efficacy of endoscopic clips in addressing post-EST bleeding, we aim to evaluate the efficacy of PHP and its noninferiority to endoscopic clips in patients with nonpulsatile post-EST bleeding. METHODS Patients with nonpulsatile post-EST bleeding were randomized to receive either PHP or endoscopic clips. The primary end point was the immediate hemostasis rate, with secondary end points including delayed bleeding rate, overall treatment success rate, mean hemostasis time, and other major complications. RESULTS A total of 104 patients with nonpulsatile post-EST bleeding were included. Immediate hemostasis was achieved in 100% of the PHP group and 92.3% in the endoscopic clip group (risk difference, 7.7%, 95% confidence interval (CI) = 0.5%-15.0%, P = 0.022). Four patients in the endoscopic clip group experienced immediate hemostasis failure. Hemostasis time was shorter in the PHP group (50.77 vs 62.81 seconds, P = 0.011). One delayed bleeding case (2.1%) occurred in the clip group, whereas none were observed in the PHP group. The overall treatment success rate was higher in the PHP group compared with the endoscopic clip group (100% vs 90.4%; P = 0.022). No differences were observed in adverse events. DISCUSSION PHP is not inferior to endoscopic clip and could be of use in immediate hemostasis for nonpulsatile post-EST bleeding, with the added advantage of ease of use. Further research is needed to assess its efficacy in preventing delayed bleeding ( chictr.org.cn , ChiCTR2400092280).
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Affiliation(s)
- Hengcun Li
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, National Clinical Research Center for Digestive Diseases, State Key Laboratory of Digestive Health, Beijing Digestive Disease Center, Beijing Key Laboratory for Precancerous Lesion of Digestive Disease, Beijing, China
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Jung DH, Park JC, Kim JS, Lee MW, Lee H, Kim GH. Evaluating the efficacy of a novel hemostatic powder compared with traditional treatments in nonvariceal upper GI bleeding: a multicenter, randomized, noninferiority study. Gastrointest Endosc 2025; 101:792-803.e1. [PMID: 39389432 DOI: 10.1016/j.gie.2024.10.002] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/18/2024] [Revised: 08/20/2024] [Accepted: 10/01/2024] [Indexed: 10/12/2024]
Abstract
BACKGROUND AND AIMS Hemostatic powders have been rapidly developed and used to treat GI bleeding. We aimed to investigate the noninferiority of the newly developed hemostatic powder (CEGP-003; CGBio, Seongnam, South Korea) compared with conventional endoscopic treatments for nonvariceal upper GI bleeding (NVUGIB). METHODS This prospective, multicenter, randomized, open-label, controlled trial was conducted at 4 referral institutions. We enrolled consecutive patients who underwent emergency endoscopy for NVUGIB. The patients were randomly assigned to either the CEGP-003 group or the conventional treatment group. In the CEGP-003 group, the hemostatic powder was applied as a spray. Conventional endoscopic treatments included electrical coagulation and use of hemostatic clips. RESULTS Between November 2019 and June 2022, 218 patients were enrolled (CEGP-003 group, 108; conventional group, 110). Initial hemostasis was achieved in 104 of 108 patients (96.3%) in the CEGP-003 group and 101 of 110 patients (91.8%) in the conventional treatment group. The CEGP-003 group exhibited a significantly higher recurrent bleeding rate than the conventional treatment group. Multivariate analysis showed that age, duodenum and middle one-third of the stomach, and CEGP-003 use as the initial hemostatic treatment were independent risk factors for recurrent bleeding. No adverse events were associated with CEGP-003. CONCLUSIONS CEGP-003 demonstrates promise as an initial endoscopic therapy for NVUGIB. However, close monitoring is warranted because of the risk of recurrent bleeding. (Clinical trial registration number: KCT0004655.).
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Affiliation(s)
- Da Hyun Jung
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Jun Chul Park
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Joon Sung Kim
- Division of Gastroenterology, Department of Internal Medicine, Incheon St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
| | - Moon Won Lee
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - Hyuk Lee
- Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Republic of Korea
| | - Gwang Ha Kim
- Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
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Liu K, Zhang W, Gao L, Bai J, Dong X, Wang Y, Chen H, Dong J, Fang N, Han Y, Liu Z. Efficacy of hemostatic powder monotherapy versus conventional endoscopic treatment for nonvariceal GI bleeding: a meta-analysis and trial sequential analysis. Gastrointest Endosc 2025; 101:539-550.e14. [PMID: 39265743 DOI: 10.1016/j.gie.2024.08.042] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/06/2024] [Revised: 08/27/2024] [Accepted: 08/31/2024] [Indexed: 09/14/2024]
Abstract
BACKGROUND AND AIMS Hemostatic powder (HP) is a novel hemostasis modality for nonvariceal GI bleeding. This meta-analysis was performed to evaluate the efficacy of HP monotherapy versus conventional endoscopic treatment (CET) for nonvariceal GI bleeding. METHODS PubMed, EMBASE, and Cochrane Library databases were systematically searched from inception to October 16, 2023. The primary outcomes were the initial hemostatic rate and the 30-day recurrent bleeding rate. After the meta-analysis, a trial sequential analysis (TSA) was also conducted to decrease the risk of random errors and validate the result. RESULTS The meta-analysis included 8 studies, incorporating 653 patients in total. Given significant heterogeneity, all analyses were segregated into malignancy-related and nonmalignancy-related GI bleeding lesions. For the former, HP monotherapy significantly improved the initial hemostasis rate and 30-day recurrent bleeding rate compared with CET (relative risk [RR], 1.50; 95% confidence interval [CI], 1.28-1.75; P < .001; RR, .32; 95% CI, .12-.86; P = .02, respectively), and TSA supported the results. For nonmalignancy-related GI bleeding, HP monotherapy and CET have similar initial hemostasis and 30-day recurrent bleeding rates (RR, 1.08; 95% CI, .98-1.19; P = .11; RR, 1.15; 95% CI, .46-2.90; P = .76, respectively), but the TSA failed to confirm the results. CONCLUSIONS HP monotherapy surpassed CET in terms of the initial hemostasis rate and 30-day recurrent bleeding rate for patients with malignancy-related GI bleeding. However, their relative efficacy for nonmalignancy-related GI bleeding remains unresolved.
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Affiliation(s)
- Kai Liu
- Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China
| | - Wei Zhang
- Department of Obstetrics and Gynecology, Ordos Central Hospital, Ordos School of Clinical Medicine, Inner Mongolia Medical University, Ordos, China
| | - Li Gao
- Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China
| | - Jiawei Bai
- Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China; Department of Gastroenterology, School of Medicine, Yan'an University, Yan'an, China
| | - Xin Dong
- Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China
| | - Yue Wang
- Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China; Department of Gastroenterology, Xi'an Medical University, Xi'an, China
| | - Hui Chen
- Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China
| | - Jiaqiang Dong
- Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China
| | - Nian Fang
- Department of Gastroenterology, Third Clinical Medical College, Nanchang University, Nanchang, China; Department of Gastroenterology, The First Hospital of Nanchang (The Third Affiliated Hospital of Nanchang University), Nanchang, China
| | - Ying Han
- Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China.
| | - Zhiguo Liu
- Department of Gastroenterology, Xijing Hospital of Digestive Diseases, Air Force Medical University (Fourth Military Medical University), Xi'an, China.
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Lim ZH, Seo SI, Myung DS, Kim SH, Lee HH, Kim S, Lee BI. Current status and clinical outcome of endoscopic hemostatic powder in gastrointestinal bleeding: a retrospective multicenter study. Clin Endosc 2024; 57:620-627. [PMID: 38454544 PMCID: PMC11474474 DOI: 10.5946/ce.2023.179] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/14/2023] [Revised: 10/11/2023] [Accepted: 10/12/2023] [Indexed: 03/09/2024] Open
Abstract
BACKGROUND/AIMS Few multicenter studies have investigated the efficacy of hemostatic powders in gastrointestinal (GI) bleeding. We aimed to investigate the clinical outcomes of hemostatic powder therapy and the independent factors affecting rebleeding rates. METHODS We retrospectively recruited patients who underwent a new hemostatic adhesive powder (UI-EWD; Next-Biomedical) treatment for upper and lower GI bleeding between January 1, 2020 and March 1, 2023. We collected patients' medical records and bleeding lesions. The primary outcomes were clinical and technical success rates, and the secondary outcomes were early, delayed, and refractory bleeding, mortality, and factors affecting early rebleeding rates. RESULTS This study enrolled 135 patients (age: 67.7±13.6 years, male: 74.1%) from five hospitals. Indications for UI-EWD were peptic ulcers (51.1%), post-procedure-related bleeding (23.0%), and tumor bleeding (19.3%). The clinical and technical success rates were both 97%. The early, delayed, and refractory rebleeding rates were 19.3%, 11.1%, and 12.8%, respectively. Initially elevated blood urea nitrogen (BUN) levels (p=0.014) and Forrest classification IA or IB compared with IIA or IIB (p=0.036) were factors affecting early rebleeding. CONCLUSIONS UI-EWD showed high clinical and technical success rates; however, rebleeding after UI-EWD therapy in patients with initially high BUN levels and active bleeding, according to the Forrest classification, should be considered.
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Affiliation(s)
- Zie Hae Lim
- Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea
| | - Seung In Seo
- Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea
| | - Dae-Seong Myung
- Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea
| | - Seung Han Kim
- Division of Gastroenterology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
| | - Han Hee Lee
- Department of Internal Medicine, Yeouido St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Selen Kim
- Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Bo-In Lee
- Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
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Chiang HC. The Risk of Polysaccharide Hemostatic Powder for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol 2024; 22:1747. [PMID: 38040275 DOI: 10.1016/j.cgh.2023.11.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/04/2023] [Revised: 11/09/2023] [Accepted: 11/13/2023] [Indexed: 12/03/2023]
Affiliation(s)
- Hsueh-Chien Chiang
- Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
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Jung DH, Park CH, Choi SI, Kim HR, Lee M, Moon HS, Park JC. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol 2023; 21:2844-2853.e5. [PMID: 36906081 DOI: 10.1016/j.cgh.2023.02.031] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/12/2022] [Revised: 02/17/2023] [Accepted: 02/28/2023] [Indexed: 03/13/2023]
Abstract
BACKGROUND & AIMS Hemostatic powders have been clinically used in the treatment of gastrointestinal bleeding. We investigated the non-inferiority of a polysaccharide hemostatic powder (PHP), compared with conventional endoscopic treatments, for peptic ulcer bleeding (PUB). METHODS This study was a prospective multi-center, randomized, open-label, controlled trial at 4 referral institutions. We consecutively enrolled patients who had undergone emergency endoscopy for PUB. The patients were randomly assigned to either a PHP or conventional treatment group. In the PHP group, diluted epinephrine was injected, and the powder was applied as a spray. Conventional endoscopic treatment included the use of electrical coagulation or hemoclipping after injection of diluted epinephrine. RESULTS Between July 2017 and May 2021, 216 patients were enrolled in this study (PHP group, 105; control group, 111). Initial hemostasis was achieved in 92 of 105 patients (87.6%) in the PHP group and 96 of 111 patients (86.5%) in the conventional treatment group. Re-bleeding did not differ between the 2 groups. In subgroup analysis, the initial hemostasis failure rate in the conventional treatment group was 13.6% for Forrest IIa cases; however, there was no initial hemostasis failure in the PHP group (P = .023). Large ulcer size (≥15 mm) and chronic kidney disease with dialysis were independent risk factors for re-bleeding at 30 days. No adverse events were associated with PHP use. CONCLUSIONS PHP is not inferior to conventional treatments and could be useful in initial endoscopic treatment for PUB. Further studies are needed to confirm the re-bleeding rate of PHP. CLINICALTRIALS gov, Number: NCT02717416).
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Affiliation(s)
- Da Hyun Jung
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Chan Hyuk Park
- Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Seoul, Korea
| | - Soo In Choi
- Division of Gastroenterology, Department of Internal Medicine, Inje University Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea
| | - Hye Rim Kim
- Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Korea
| | - Myeongjee Lee
- Biostatistics Collaboration Unit, Department of Biomedical Systems Informatics, Yonsei University College of Medicine, Seoul, Korea
| | - Hee Seok Moon
- Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea.
| | - Jun Chul Park
- Division of Gastroenterology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
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Hemostatic Powders in Non-Variceal Upper Gastrointestinal Bleeding: The Open Questions. MEDICINA (KAUNAS, LITHUANIA) 2023; 59:medicina59010143. [PMID: 36676767 PMCID: PMC9863809 DOI: 10.3390/medicina59010143] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 12/06/2022] [Revised: 01/03/2023] [Accepted: 01/05/2023] [Indexed: 01/12/2023]
Abstract
Hemostatic powder (HP) is a relatively recent addition to the arsenal of hemostatic endoscopic procedures (HEPs) for gastrointestinal bleeding (GIB) due to benign and malignant lesions. Five types of HP are currently available: TC-325 (Hemospray™), EndoClot™, Ankaferd Blood Stopper®, and, more recently, UI-EWD (NexpowderTM) and CEGP-003 (CGBio™). HP acts as a mechanical barrier and/or promotes platelet activation and coagulation cascade. HP may be used in combination with or as rescue therapy in case of failure of conventional HEPs (CHEPs) and also as monotherapy in large, poorly accessible lesions with multiple bleeding sources. Although the literature on HP is abundant, randomized controlled trials are scant, and some questions remain open. While HP is highly effective in inducing immediate hemostasis in GIB, the rates of rebleeding reported in different studies are very variable, and conditions affecting the stability of hemostasis have not yet been fully elucidated. It is not established whether HP as monotherapy is appropriate in severe GIB, such as spurting peptic ulcers, or should be used only as rescue or adjunctive therapy. Finally, as it can be sprayed on large areas, HP could become the gold standard in malignancy-related GIB, which is often nonresponsive or not amenable to treatment with CHEPs as a result of multiple bleeding points and friable surfaces. This is a narrative review that provides an overview of currently available data and the open questions regarding the use of HP in the management of non-variceal upper GIB due to benign and malignant diseases.
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Jiang SX, Chahal D, Ali-Mohamad N, Kastrup C, Donnellan F. Hemostatic powders for gastrointestinal bleeding: a review of old, new, and emerging agents in a rapidly advancing field. Endosc Int Open 2022; 10:E1136-E1146. [PMID: 36238531 PMCID: PMC9552790 DOI: 10.1055/a-1836-8962] [Citation(s) in RCA: 25] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/15/2022] [Accepted: 04/20/2022] [Indexed: 10/26/2022] Open
Abstract
Background and study aims Hemostatic powders are increasingly used to address limitations in conventional endoscopic techniques for gastrointestinal bleeding. Various agents exist with different compositions, characteristics, efficacy, and adverse events (AEs). We sought to review existing hemostatic powders, from preclinical to established agents. Methods A literature review on hemostatic powders for gastrointestinal bleeding was undertaken through a MEDLINE search from 2000-2021 and hand searching of articles. Relevant literature was critically appraised and reviewed for mechanism of action, hemostasis and rebleeding rate, factors associated with hemostatic failure, and AEs. Results The most established agents are TC-325 (Hemospray), EndoClot, and Ankaferd Blood Stopper (ABS). These agents have been successfully applied to a variety of upper and lower gastrointestinal bleeding etiologies, in the form of primary, combination, salvage, and bridging therapy. Few AEs have been reported, including visceral perforation, venous embolism, and self-limited abdominal pain. Newer agents include CEGP-003 and UI-EWD, which have shown results similar to those for the older agents in initial clinical studies. All aforementioned powders have high immediate hemostasis rates, particularly in scenarios not amenable to conventional endoscopic methods, but are limited by significant rates of rebleeding. Other treatments include TDM-621 (PuraStat) consisting of a liquid hemostatic agent newly applied to endoscopy and self-propelling thrombin powder (CounterFlow Powder), a preclinical but promising agent. Conclusions Rapid development of hemostatic powders and growing clinical expertise has established these agents as a valuable strategy in gastrointestinal bleeding. Further research will continue to refine the efficacy and applicability of these agents.
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Affiliation(s)
- Shirley X. Jiang
- Department of Medicine, University of British Columbia, Vancouver, BC, Canada
| | - Daljeet Chahal
- Division of Gastroenterology, Mount Sinai Hospital, New York, New York, United States
| | - Nabil Ali-Mohamad
- Michael Smith Laboratories, University of British Columbia, Vancouver, BC, Canada
- Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada
| | - Christian Kastrup
- Michael Smith Laboratories, University of British Columbia, Vancouver, BC, Canada
- Blood Research Institute, Versiti, Milwaukee, Wisconsin, United States
| | - Fergal Donnellan
- Division of Gastroenterology, University of British Columbia, Vancouver General Hospital, Vancouver, BC, Canada
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FDG PET/CT Features of Polysaccharide-Based Hemostatic Agent: Chronic Inflammatory Changes Can Mimic Metastatic Lesions. Clin Nucl Med 2022; 47:e475-e480. [PMID: 35452003 DOI: 10.1097/rlu.0000000000004216] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
PURPOSE To prevent hemorrhagic complications, hemostatic agents (HAs) have been widely used in recent years. The use of HAs can lead to false-positive results on postoperative imaging. There exists only 1 study in the literature evaluating these applications during surgical procedures. Therefore, we aimed to evaluate the postoperative imaging features of polysaccharide-based HAs in thoracic surgery patients who have had 18F-FDG PET/CT scans. PATIENTS AND METHODS Two hundred nine consecutive patients who underwent thoracic surgery were enrolled in this study. A topical polysaccharide-based HA was applied to the surgical bed for all of the patients. The patients diagnosed with cancer were followed up with subsequent thoracic CT scans, and 42 of these patients were also imaged with 18F-FDG PET/CT, which then comprised the main study group. Due to suspicion of metastasis, 19/42 patients were reoperated or rebiopsied. The latest histopathological findings were accepted as criterion standard, and previous FDG PET/CT images were retrospectively reevaluated. RESULTS Polysaccharide-based HAs that appear as amorphous basophilic material were identified in histopathological samples of 11/19 patients. Lymphocytes, plasma cells, and histiocytes, which formed foreign body reaction and/or foreign body granuloma, indicating the presence of chronic inflammation, were seen in all of the samples. 18F-FDG PET/CT showed increased FDG uptake in all of these lesions. CONCLUSIONS Despite the inconsistency of the literature, polysaccharide-based HAs can be demonstrated in human surgical specimens as amorphous basophilic materials even after a long time from the initial surgical procedure. These agents almost always cause chronic inflammatory changes. In addition, these agents may mimic "false-positive" findings on postoperative FDG PET/CT scans.
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Chahal D, Lee JGH, Ali-Mohamad N, Donnellan F. High rate of re-bleeding after application of Hemospray for upper and lower gastrointestinal bleeds. Dig Liver Dis 2020; 52:768-772. [PMID: 32127325 DOI: 10.1016/j.dld.2020.01.009] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/08/2019] [Revised: 01/18/2020] [Accepted: 01/23/2020] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Hemospray (TC-325, Cook Medical) has recently been approved for use in GI bleeding. Specific clinical indications and predictors of success or failure have not been well delineated. METHODS We conducted a retrospective cohort study of Hemospray use at a tertiary center. We assessed demographics and characteristics of Hemospray use. We analyzed outcomes of hemostasis, rebleeding, need for embolization or surgery, and death. RESULTS 86 applications of Hemospray were identified. The most common etiology of upper GI bleeds were ulcers (67.1%) whilst the etiology of lower GI bleeds varied. Hemospray was applied as monotherapy in 28 procedures (32.6%). Immediate hemostasis rate was 88.4%, but there was a high rate of re-bleeding (33.7%). Most re-bleeds occurred within 7 days (86.2%). Syncope was an independent predictive factor re-bleeding at 7 days for EGD (OR = 12.16, 95% CI = 1.51-97.75, P = 0.019). Bleeding refractory to endoscopic treatment with hemospray required radiological embolization in 9 instances, and surgery in 9 instances. Hemospray therapy was protective against need for embolization (p < 0.05). 2 patients underwent liver transplantation and there was a total of 5 deaths. Hepatic disease was an independent predictor of death (OR = 47.15, 95% CI = 2.42-916.89, P = 0.011). CONCLUSION Hemospray is effective in achieving immediate hemostasis but is plagued by high rates of rebleeding. Syncope is a predictor of rebleeding, and hepatic disease is a predictor of death in patients undergoing Hemospray therapy. Despite high rates of embolization and surgery, Hemospray may reduce need for embolization. Hemospray use during endoscopy should prompt physicians to consider early re-look endoscopy and more aggressive therapy.
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Affiliation(s)
- Daljeet Chahal
- Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
| | - Joseph G H Lee
- Department of Medicine, University of British Columbia, Vancouver, BC, Canada
| | | | - Fergal Donnellan
- Department of Medicine, Division of Gastroenterology, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada
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Lee DH, Ko W. Hemostatic materials in non-variceal upper gastrointestinal hemorrhage. INTERNATIONAL JOURNAL OF GASTROINTESTINAL INTERVENTION 2020. [DOI: 10.18528/ijgii190015] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Affiliation(s)
- Don Haeng Lee
- Division of Gastroenterology, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea
- Utah-Inha DDS and Advanced Therapeutics Research Center, Incheon, Korea
| | - Weonjin Ko
- Division of Gastroenterology, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea
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Naseer M, Lambert K, Hamed A, Ali E. Endoscopic advances in the management of non-variceal upper gastrointestinal bleeding: A review. World J Gastrointest Endosc 2020; 12:1-16. [PMID: 31942229 PMCID: PMC6939122 DOI: 10.4253/wjge.v12.i1.1] [Citation(s) in RCA: 25] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/30/2019] [Revised: 08/28/2019] [Accepted: 10/19/2019] [Indexed: 02/06/2023] Open
Abstract
Upper gastrointestinal bleeding is defined as the bleeding originating from the esophagus to the ligament of Treitz and further classified into variceal and non-variceal gastrointestinal bleeding. Non-variceal upper gastrointestinal bleeding remains a common clinical problem globally. It is associated with high mortality, morbidity, and cost of the health care system. Despite the continuous improvement of therapeutic endoscopy, the 30-d readmission rate secondary to rebleeding and associated mortality is an ongoing issue. Available Food and Drug Administration approved traditional or conventional therapeutic endoscopic modalities includes epinephrine injection, argon plasma coagulation, heater probe, and placement of through the scope clip, which can be used alone or in combination to decrease the risk of rebleeding. Recently, more attention has been paid to the novel advanced endoscopic devices for primary treatment of the bleeding lesion and as a secondary measure when conventional therapies fail to achieve hemostasis. This review highlights emerging endoscopic modalities used in the management of non-variceal upper gastrointestinal related bleeding such as over-the-scope clip, Coagrasper, hemostatic sprays, radiofrequency ablation, cryotherapy, endoscopic suturing devices, and endoscopic ultrasound-guided angiotherapy. In this review article, we will also discuss the technical aspects of the common procedures, outcomes in terms of safety and efficacy, and their advantages and limitations in the setting of non-variceal upper gastrointestinal bleeding.
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Affiliation(s)
- Maliha Naseer
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, East Carolina University, Greenville, NC 27834, United States
| | - Karissa Lambert
- Department of Internal Medicine, East Carolina University, Greenville, NC 27834, United States
| | - Ahmed Hamed
- Department of Internal Medicine, East Carolina University, Greenville, NC 27834, United States
| | - Eslam Ali
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, East Carolina University, Greenville, NC 27834, United States
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Facciorusso A, Straus Takahashi M, Eyileten Postula C, Buccino VR, Muscatiello N. Efficacy of hemostatic powders in upper gastrointestinal bleeding: A systematic review and meta-analysis. Dig Liver Dis 2019; 51:1633-1640. [PMID: 31401022 DOI: 10.1016/j.dld.2019.07.001] [Citation(s) in RCA: 37] [Impact Index Per Article: 6.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/25/2019] [Revised: 07/03/2019] [Accepted: 07/08/2019] [Indexed: 12/11/2022]
Abstract
BACKGROUND There is limited evidence on the efficacy of hemostatic powders in the management of upper gastrointestinal bleeding. AIMS Provide a pooled estimate of the efficacy and safety profile of hemostatic powders in digestive endoscopy. METHODS A computerized bibliographic search on the main databases was performed through December 2018. Pooled effects were calculated using a random-effects model. The primary outcome was immediate hemostasis rate. Secondary outcomes were rebleeding rate (either at 7 and 30 days), bleeding-related mortality, and all-cause mortality rate. RESULTS A total of 24 studies, of which three were randomized-controlled trials, with 1063 patients were included in the meta-analysis. Immediate hemostasis was achieved in 95.3% (93.3%-97.3%) of patients, with no difference based on treatment strategy, hemostatic agent used, bleeding etiology. Success rate was slightly lower in spurting bleeding (91.9%). Hemostatic powders showed similar efficacy as compared to conventional endoscopic therapy (odds ratio: 0.84, 0.06-11.47; p = 0.9). Thirty-day rebleeding rate was 16.9% (9.8%-24%) with no difference in comparison to other endoscopic treatments (odds ratio 1.59, 0.35-7.21; p = 0.55). All-cause and bleeding-related mortality rates were 7.6% (4%-10.8%) and 1.4% (0.5%-2.4%), respectively. CONCLUSION Novel hemostatic powders represent a user-friendly and effective tool in the management of upper gastrointestinal bleeding.
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Vitali F, Naegel A, Atreya R, Zopf S, Neufert C, Siebler J, Neurath MF, Rath T. Comparison of Hemospray ® and Endoclot ™ for the treatment of gastrointestinal bleeding. World J Gastroenterol 2019; 25:1592-1602. [PMID: 30983819 PMCID: PMC6452236 DOI: 10.3748/wjg.v25.i13.1592] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/22/2018] [Revised: 03/06/2019] [Accepted: 03/11/2019] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Gastrointestinal (GI) bleeding is a common indication for endoscopy. For refractory cases, hemostatic powders (HP) represent "touch-free" agents. AIM To analyze short term (ST-within 72 h-) and long-term (LT-within 30 d-) success for achieving hemostasis with HP and to directly compare the two agents Hemospray (HS) and Endoclot (EC). METHODS HP was applied in 154 consecutive patients (mean age 67 years) with GI bleeding. Patients were followed up for 1 mo (mean follow-up: 3.2 mo). RESULTS Majority of applications were in upper GI tract (89%) with following bleeding sources: peptic ulcer disease (35%), esophageal varices (7%), tumor bleeding (11.7%), reflux esophagitis (8.7%), diffuse bleeding and erosions (15.3%). Overall ST success was achieved in 125 patients (81%) and LT success in 81 patients (67%). Re-bleeding occurred in 27% of all patients. In 72 patients (47%), HP was applied as a salvage hemostatic therapy, here ST and LT success were 81% and 64%, with re-bleeding in 32%. As a primary hemostatic therapy, ST and LT success were 82% and 69%, with re-bleeding occurring in 22%. HS was more frequently applied for upper GI bleeding (P = 0.04). CONCLUSION Both HP allow for effective hemostasis with no differences in ST, LT success and re-bleeding.
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Affiliation(s)
- Francesco Vitali
- Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, Erlangen 91054, Germany
| | - Andreas Naegel
- Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, Erlangen 91054, Germany
| | - Raja Atreya
- Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, Erlangen 91054, Germany
| | - Steffen Zopf
- Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, Erlangen 91054, Germany
| | - Clemens Neufert
- Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, Erlangen 91054, Germany
| | - Juergen Siebler
- Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, Erlangen 91054, Germany
| | - Markus F Neurath
- Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, Erlangen 91054, Germany
| | - Timo Rath
- Ludwig Demling Endoscopy Center of Excellence, Division of Gastroenterology, Friedrich-Alexander-University, Erlangen 91054, Germany
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Abstract
PURPOSE OF REVIEW To review new advances in managing nonvariceal upper gastrointestinal hemorrhage. RECENT FINDINGS Implementation of various scoring systems in combination with video capsule endoscopy assists in stratifying and managing nonvariceal upper gastrointestinal bleeding. New techniques such as thermocoagulation and hemoclips are useful to treat bleeding. SUMMARY The advancement of methods and procedures in managing nonvariceal upper gastrointestinal bleeding has decreased mortality of patients presenting with this type of hemorrhage. In this chapter, we will be discussing various scores to stratify nonvariceal upper gastrointestinal bleeding and techniques to stop bleeding.
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Cho YS. New endoscopic techniques in treating gastrointestinal bleeding. INTERNATIONAL JOURNAL OF GASTROINTESTINAL INTERVENTION 2018. [DOI: 10.18528/gii180025] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/26/2023] Open
Affiliation(s)
- Young Sin Cho
- Division of Gastroenterology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, Korea
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Cipolletta L, Cipolletta F, Granata A, Ligresti D, Barresi L, Tarantino I, Traina M. What Is the Best Endoscopic Strategy in Acute Non-variceal Gastrointestinal Bleeding? ACTA ACUST UNITED AC 2018; 16:363-375. [PMID: 30229463 DOI: 10.1007/s11938-018-0192-0] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
OPINION STATEMENT PURPOSE OF REVIEW: Upper non-variceal gastrointestinal bleeding (UNVGIB) remains an important clinical challenge for endoscopists, requiring skill and expertise for correct management. In this paper, we suggest the best strategy for an effective treatment of this complex category of patients. RECENT FINDINGS Early endoscopic examination, the increasingly widespread use of endoscopic hemostasis methods, and the most powerful antisecretory agents that induce clot stabilization have radically modified the clinical scenario for treating this pathology. While hospitalization for digestive hemorrhage is decreasing, the incidence of bleeding seems to be increasing, especially in the elderly for whom a greater use of gastrolesive drugs and the presence of comorbidities are more common. A multidisciplinary approach for initial patient evaluation and hemodynamic resuscitation prior to endoscopic treatment is crucial for correct management, prevention of rebleeding, and reduction of morbidity and mortality rates and hospital stays. Appropriate operator technical expertise, together with the availability of a wide range of endoscopes and devices, is mandatory. Newer endoscopic techniques may improve patient outcomes for difficult-to-treat lesions. Today, endoscopic hemostasis can be achieved in over 95% of patients.
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Affiliation(s)
- Livio Cipolletta
- Endoscopy Unit, Ruesch Clinic, Via San Domenico, 24, 80127, Naples, Italy.
| | - Fabio Cipolletta
- Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy
| | - Antonino Granata
- Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy
| | - Dario Ligresti
- Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy
| | - Luca Barresi
- Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy
| | - Ilaria Tarantino
- Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy
| | - Mario Traina
- Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy
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