A new protective gel to facilitate ulcer healing in artificial ulcers following esophageal endoscopic submucosal dissection: A multicenter, randomized trial

Abstract

There are significant risks of adverse events such as stricture, delayed bleeding and perforation following esophageal endoscopic submucosal dissection (ESD). So, it is necessary to protect the artificial ulcer and promote the healing process. This study was performed to investigate the protective role of a novel gel against esophageal ESD-associated wounds. It was a multicenter, randomized, single-blind, controlled trial, which recruited participants who underwent esophageal ESD in four hospitals in China. Participants were randomly assigned to the control or experimental group in a 1:1 ratio and the gel was used after ESD in the latter. Masking of the study group allocations was only attempted for participants. The participants were instructed to report any adverse events on post-ESD day 1, 14, and 30. Moreover, repeat endoscopy was performed at the two-week follow-up to confirm wound healing. Finally, of the 92 recruited patients, 81 completed the study. In the experimental group, the healing rates were significantly higher than the control group (83.89 ± 9.51% vs. 73.28 ± 17.81%, P = 0.0013). Participants reported no severe adverse events during the follow-up period. In conclusion, this novel gel could accelerate wound healing following esophageal ESD safely, effectively, and conveniently. Therefore, we recommend to apply this gel in daily clinical practice.