Use of over-the-scope clip (OTSC) versus standard therapy for the prevention of rebleeding in large peptic ulcers (size ≥1.5 cm): an open-labelled, multicentre international randomised controlled trial

Shannon Chan, Rapat Pittayanon, Hsiu-Po Wang, Jiann-Hwa Chen, Anthony Yb Teoh, Yu Ting Kuo, Raymond Sy Tang, Hon Chi Yip, Stephen Ka Kei Ng, Sunny Wong, Joyce Wing Yan Mak, Heyson Chan, Louis Lau, Rashid N Lui, Marc Wong, Rungsun Rerknimitr, Enders K Ng, Philip Wai Yan Chiu, Shannon Chan, Rapat Pittayanon, Hsiu-Po Wang, Jiann-Hwa Chen, Anthony Yb Teoh, Yu Ting Kuo, Raymond Sy Tang, Hon Chi Yip, Stephen Ka Kei Ng, Sunny Wong, Joyce Wing Yan Mak, Heyson Chan, Louis Lau, Rashid N Lui, Marc Wong, Rungsun Rerknimitr, Enders K Ng, Philip Wai Yan Chiu

Abstract

Introduction: Over-the-scope clip (OTSC) has been used recently for primary haemostasis of peptic ulcers. This study aimed to compare the efficacy of OTSC to standard endoscopic therapy in primary treatment of patients with peptic ulcer bleeding that are of size ≥1.5 cm. The target population accounts for only 2.5% of all upper GI bleeders.

Methods: This was a multicentre international randomised controlled trial from July 2017 to October 2020. All patients with Forest IIa or above peptic ulcers of ≥1.5 cm were included. Primary outcome was 30-day clinical rebleeding. Secondary endpoints include 3-day all-cause mortality, transfusion requirement, hospital stay, technical and clinical success, and further interventions. 100 patients are needed to yield a power of 80% to detect a difference of -0.15 at the 0.05 significance level (alpha) using a two-sided Z-test (pooled).

Results: 100 patients were recruited. Success in achieving primary haemostasis was achieved in 46/50 (92%) and 48/50 (96%) in the OTSC and conventional arm, respectively. Among patients who had success in primary haemostasis, 2/46 (4.35%) patients in the OTSC arm and 9/48 (18.75%) patients in the conventional arm developed 30-day rebleeding (p=0.03). However, in an intention-to-treat analysis, there was no difference in rebleeding within 30 days (5/50 (10%) OTSC vs 9/50 (18%) standard, p=0.23) or all-cause mortality (2/50 (4%) OTSC vs 4/50 (8%) standard, p=0.68; OR=2.09, 95% CI 0.37 to 11.95). There was also no difference in transfusion requirement, hospital stay, intensive care unit admission and further interventions.

Conclusion: The routine use of OTSC as primary haemostasis in large bleeding peptic ulcers was not associated with a significant decrease in 30-day rebleeding.

Trial registration number: NCT03160911.

Keywords: bleeding peptic ulcer; endoscopy; gastrointestinal bleeding.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
An OTSC being applied over a visible vessel at first part of duodenum. OTSC, over-the-scope clip.
Figure 2
Figure 2
Consolidated Standards of Reporting Trials diagram. CPH, ChengDu 2nd people’s Hospital; CU, Chulalongkorn University; NDH, North District Hospital; NTU, National Taiwan University; PWH, Prince of Wales Hospital; TPH, Taipei Tzu Chi Hospital.
Figure 3
Figure 3
Participant flow diagram with clinical rebleeding rates. OTSC, over-the-scope clip.
Figure 4
Figure 4
Kaplan-Meier curve showing the clinical rebleeding in 30days (log-rank test, p=0.23). OTSC, over-the-scope clip.
Figure 5
Figure 5
Kaplan -Meier curve showing clinical rebleeding within 30 days of therapy in patients who had technical success. (log rank test who had technical success. (log RANK-rank test, pp=0.03)). OTSC, over-the-scope clip.

References

    1. Gralnek IM, Barkun AN, Bardou M. Management of acute bleeding from a peptic ulcer. N Engl J Med 2008;359:928–37. 10.1056/NEJMra0706113
    1. van Leerdam ME. Epidemiology of acute upper gastrointestinal bleeding. Best Pract Res Clin Gastroenterol 2008;22:209–24. 10.1016/j.bpg.2007.10.011
    1. Cook DJ, Guyatt GH, Salena BJ, et al. . Endoscopic therapy for acute nonvariceal upper gastrointestinal hemorrhage: a meta-analysis. Gastroenterology 1992;102:139–48. 10.1016/0016-5085(92)91793-4
    1. Therapeutic endoscopy and bleeding ulcers . National Institutes of health consensus development conference consensus statement 1989;7:1–7.
    1. Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol 2012;107:345–60. 10.1038/ajg.2011.480
    1. Marmo R, Koch M, Cipolletta L, et al. . Predicting mortality in patients with in-hospital nonvariceal upper Gi bleeding: a prospective, multicenter database study. Gastrointest Endosc 2014;79:741–9. 10.1016/j.gie.2013.10.009
    1. Chiu PWY, Ng EKW, Cheung FKY, et al. . Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol 2009;7:311–6. quiz 253. 10.1016/j.cgh.2008.08.044
    1. Marmo R, Rotondano G, Piscopo R, et al. . Dual therapy versus monotherapy in the endoscopic treatment of high-risk bleeding ulcers: a meta-analysis of controlled trials. Am J Gastroenterol 2007;102:279–89. quiz 469. 10.1111/j.1572-0241.2006.01023.x
    1. Lo C-C, Hsu P-I, Lo G-H, et al. . Comparison of hemostatic efficacy for epinephrine injection alone and injection combined with hemoclip therapy in treating high-risk bleeding ulcers. Gastrointest Endosc 2006;63:767–73. 10.1016/j.gie.2005.11.048
    1. Gralnek IM, Dumonceau J-M, Kuipers EJ, et al. . Diagnosis and management of nonvariceal upper gastrointestinal hemorrhage: European Society of gastrointestinal endoscopy (ESGE) guideline. Endoscopy 2015;47:a1–46. 10.1055/s-0034-1393172
    1. Naegel A, Bolz J, Zopf Y, et al. . Hemodynamic efficacy of the over-the-scope clip in an established porcine cadaveric model for spurting bleeding. Gastrointest Endosc 2012;75:152–9. 10.1016/j.gie.2011.08.009
    1. Baron TH, Song LMWK, Ross A, et al. . Use of an over-the-scope clipping device: multicenter retrospective results of the first U.S. experience (with videos). Gastrointest Endosc 2012;76:202–8. 10.1016/j.gie.2012.03.250
    1. Chan SM, Chiu PWY, Teoh AYB, et al. . Use of the Over-The-Scope clip for treatment of refractory upper gastrointestinal bleeding: a case series. Endoscopy 2014;46:428–31. 10.1055/s-0034-1364932
    1. Goenka MK, Rai VK, Goenka U, et al. . Endoscopic management of gastrointestinal leaks and bleeding with the Over-the-Scope clip: a prospective study. Clin Endosc 2017;50:58–63. 10.5946/ce.2016.028
    1. Kirschniak A, Subotova N, Zieker D, et al. . The Over-The-Scope clip (OTSC) for the treatment of gastrointestinal bleeding, perforations, and fistulas. Surg Endosc 2011;25:2901–5. 10.1007/s00464-011-1640-2
    1. Manta R, Galloro G, Mangiavillano B, et al. . Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute Gi bleeding after failure of conventional techniques. Surg Endosc 2013;27:3162–4. 10.1007/s00464-013-2871-1
    1. Repici A, Arezzo A, De Caro G, et al. . Clinical experience with a new endoscopic over-the-scope clip system for use in the Gi tract. Dig Liver Dis 2009;41:406–10. 10.1016/j.dld.2008.09.002
    1. Lau JYW, Pittayanon R, Wong K-T, et al. . Prophylactic angiographic embolisation after endoscopic control of bleeding to high-risk peptic ulcers: a randomised controlled trial. Gut 2019;68:796–803. 10.1136/gutjnl-2018-316074
    1. Lau JY, Sung JJ, Lee KK, et al. . Effect of intravenous omeprazole on recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. N Engl J Med 2000;343:310–6. 10.1056/NEJM200008033430501
    1. Schmidt A, Gölder S, Goetz M, et al. . Over-the-Scope clips are more effective than standard endoscopic therapy for patients with recurrent bleeding of peptic ulcers. Gastroenterology 2018;155:674–86. 10.1053/j.gastro.2018.05.037
    1. Brandler J, Baruah A, Zeb M, et al. . Efficacy of Over-the-Scope clips in management of high-risk gastrointestinal bleeding. Clin Gastroenterol Hepatol 2018;16:690–6. 10.1016/j.cgh.2017.07.020
    1. Jensen DM, Kovacs T, Ghassemi KA, et al. . Randomized controlled trial of Over-the-Scope clip as initial treatment of severe Nonvariceal upper gastrointestinal bleeding. Clin Gastroenterol Hepatol 2021;19:2315–23. 10.1016/j.cgh.2020.08.046

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