The effect of PPIs Alone, PPIs plus cytoprotective agent, and H2RA plus cytoprotective agent on ulcer healing after endoscopic submucosal dissection: A prospective randomized controlled trial

Abstract

Background and study aims: Endoscopic submucosal dissection (ESD) is the most effective treatment for early gastric cancer or gastric adenoma. However, ESD results in iatrogenic ulcers and postoperative bleeding from ulcers. This study aimed to evaluate the effect of using a proton pump inhibitor (PPI) alone, a PPI + rebamipide combination therapy, and an H2 receptor antagonist (H2RA) + rebamipide combination therapy on ulcer healing after ESD.

Patients and methods: A total of 204 patients who underwent ESD from April 2014 to July 2017 at Dong-A University Hospital were randomly assigned to the following groups: PPI-alone group, PPI + rebamipide combination therapy group, and H2RA + rebamipide combination therapy group. However, only 156 patients were studied since we excluded those who were lost to follow-up or had diseases other than early gastric cancer or gastric adenoma. Twenty-eight days after ESD, we evaluated the ulcer residual ratio, S stage rates, ulcer bleeding ratio, and gastric pH.

Results: This study included 156 patients (PPI-alone group: 52 patients; PPI + rebamipide group: 52 patients; H2RA + rebamipide group: 52 patients). The ulcer residual ratios were 24.3 ± 14.2%, 17.0 ± 12.1%, and 21.0 ± 13.8% in the PPI alone, PPI + rebamipide, and H2RA + rebamipide groups, respectively (P = 0.048).

Conclusions: PPI + rebamipide was more effective in reducing the ulcer residual ratio after ESD. There was no statistical difference in ulcer stage and delayed bleeding after ESD among the groups. These findings showed that PPI + rebamipide had limited benefits after ESD.

Keywords: Anti-ulcer agents; Endoscopic submucosal dissection; Gastrointestinal hemorrhage; Proton pump inhibitors; Ulcer.