PT  - JOURNAL ARTICLE
AU  - Shannon Chan
AU  - Rapat Pittayanon
AU  - Hsiu-Po Wang
AU  - Jiann-Hwa Chen
AU  - Anthony YB Teoh
AU  - Yu Ting Kuo
AU  - Raymond SY Tang
AU  - Hon Chi Yip
AU  - Stephen Ka Kei Ng
AU  - Sunny Wong
AU  - Joyce Wing Yan Mak
AU  - Heyson Chan
AU  - Louis Lau
AU  - Rashid N Lui
AU  - Marc Wong
AU  - Rungsun Rerknimitr
AU  - Enders K Ng
AU  - Philip Wai Yan Chiu
TI  - 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
AID  - 10.1136/gutjnl-2022-327007
DP  - 2023 Apr 01
TA  - Gut
PG  - 638--643
VI  - 72
IP  - 4
4099  - http://gut.bmj.com/content/72/4/638.short
4100  - http://gut.bmj.com/content/72/4/638.full
SO  - Gut2023 Apr 01; 72
AB  - 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.All data relevant to the study are included in the article or uploaded as supplementary information.