Clip Closure Prevents Bleeding after Endoscopic Resection of Large Colon Polyps in a Randomized Trial.

BACKGROUND & AIMS Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. METHODS We performed a multicenter, randomized trial of patients with a large non-pedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, post-procedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included post-procedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. RESULTS Nine hundred nineteen patients were randomly assigned to groups and completed follow up. Post-procedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD], 3.6%; 95% CI, 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD, 6.3%; 95% CI, 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD, -2.6%; 95% CI, -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD, 4.6%; 95% CI, 1.3%-8.0%). CONCLUSIONS In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of post-procedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon.