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

Abstract

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 nonpedunculated 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, postprocedure 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 postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event.

Results: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure 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% confidence interval [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 postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.

Keywords: Colonoscopy; Complications; Endoscopic Mucosal Resection; Polyp Resection.

Conflict of interest statement

Conflicts of interest

These authors disclose the following: Heiko Pohl has received research funding from Boston Scientific and US Endoscopy. Ian Grimm, Matthew T. Moyer, and Abraham Mathew are consultants for Boston Scientific. Douglas Pleskow is a consultant for Olympus, Boston Scientific, and Medtronic. Mouen Khashab is a consultant and on the medical advisory board for Boston Scientific and Olympus, and a consultant for Medtronic. Seth Crockett is supported in part by a grant from the National Institutes of Health (KL2TR001109), and received research funding from Exact Sciences, Colowrap. Daniel von Renteln is supported by a Fonds de Recherche du Québec Santé career development award, has received research funding from Erbe, Ventage Pentax and is a consultant for Boston Scientific. Maria Pellise is a consultant for Norgine Iberia. Douglas Pleskow is a consultant for Olympus, Boston Scientific, and Medtronic. Douglas K. Rex is a consultant for Olympus Corp and Boston Scientific; and a research support recipient from Boston Scientific, Endochoice, EndoAid, Medtronic, and Colonary Solutions. The remaining authors disclose no conflicts. The views expressed in this article are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the US government.

Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1.

Postprocedure bleeding, primary outcome and subgroup analyses.