Prophylactic clip closure after endoscopic submucosal dissection of large flat and sessile colorectal polyps: a multicentre randomised controlled trial (EPOC trial)
Akihiro Miyakawa, Yuzuru Tamaru, Takeshi Mizumoto, Noriyoshi Kanazawa, Shiori Uchiyama, Kosuke Maehara, Yorinobu Sumida, Akira Nakamura, Ei Itobayashi, Haruhisa Shimura, Yoshio Suzuki, Tomoyuki Akita, Kenji Shimura, Toshio Kuwai
Abstract
BACKGROUND: Prophylactic clip closure after endoscopic mucosal resection reduces delayed bleeding in large and proximal colon lesions; however, evidence regarding its effectiveness in colorectal endoscopic submucosal dissection (ESD) is lacking. OBJECTIVE: To compare clinically significant delayed bleeding rates between a clip closure and a control group for flat and sessile 20-50 mm colorectal polyps following ESD. DESIGN: A multicentre randomised controlled trial conducted at four Japanese institutions randomly assigned patients to closure or non-closure groups. Significant postprocedural bleeding (haematochezia) was classified as severe (requiring endoscopic haemostasis or blood transfusion in patients with haemoglobin levels <70 g/L or haemorrhagic shock) or mild. RESULTS: The closure and control groups comprised 150 and 149 cases in the intention-to-treat (ITT) analysis and 142 and 141 cases in the per-protocol (PP) analysis, respectively. Rates of complete clip closure were 88.7% (ITT) and 93.0% (PP). The ITT analysis revealed delayed bleeding rates of 6.7% and 20.1% (OR: 0.28; 95% CI: 0.13 to 0.60; p<0.001; absolute risk difference (ARD): 13.5%; 95% CI: 5.6% to 20.9%) and severe delayed bleeding rates of 1.3% and 8.7% (OR: 0.14; 95% CI: 0.03 to 0.64; p=0.003; ARD: 7.4%; 95% CI: 2.2% to 12.4%) in the closure and control groups, respectively. These differences were confirmed in the PP analysis. Delayed perforation was not observed, and the post-ESD coagulation syndrome rate was not significantly different between the two groups. Multivariate logistic regression analyses identified prophylactic clip closure as a significant independent preventive factor for both delayed bleeding (OR: 0.22; 95% CI: 0.08 to 0.50; p<0.001) and severe delayed bleeding (OR: 0.22; 95% CI: 0.05 to 0.76; p=0.015). CONCLUSIONS: Prophylactic clip closure, successfully achieved in approximately 90% of cases, reduced the delayed bleeding rate after resection of colorectal polyps measuring 20-50 mm. TRIAL REGISTRATION NUMBER: UMIN000043675.