A novel self-assembled gel protects against endoscopic resection- induced colonic ulcers: a randomized clinical trial A novel gel that could promote ulcer healing

Abstract Background: Although associated with high en bloc and complete resection rates, endoscopic resection, which is widely performed for gastrointestinal mucosal and submucosal lesions, may cause bleeding and perforation. However, novel agents are being introduced to minimize these complications. Methods: In this multicenter, randomized, single blind, controlled trial, participants who underwent colonic endoscopic resection across four hospitals in China were randomly assigned to the control or experimental group(1:1 ratio); the gel was used after colonic endoscopic resection in the latter. Participants were instructed to report adverse events on the first day, 14th day, and one-month post-intervention. Repeat endoscopy was performed at two-week follow-up to confirm resection site healing. Results: Of the 92 screened participants, 73 completed the study. Each ulcer bed was successfully coated with the gel over an 87.4±13.4% area within approximately three minutes in the experimental group. The calculated healing rates were significantly higher in the experimental than in the control group (84.7±10.8% vs. 72.6±16.0%, P=0.0004). No severe relative adverse event occurred during follow-up. Conclusions: This novel gel is a safe, effective, and convenient agent that promotes wound healing after colonic endoscopic resection. And we recommend application of this gel to protect the ulcer bed in daily clinical practice. Trial registration This trial has been registered in Chinese Clinical Trial Registry (ChiCTR2100053692).