Effect of a proton pump inhibitor or an H₂-receptor antagonist on prevention of bleeding from ulcer after endoscopic submucosal dissection of early gastric cancer: A prospective randomized controlled trial

OBJECTIVES: With conventional methods of endoscopic mucosal resection for early gastric cancer (EGC), proton pump inhibitors (PPIs) and H ₂-receptor antagonists (H₂RAs) have a similar effect on preventing bleeding from artificial ulcers. An objective of this study is to investigate whether a stronger acid suppressant (i.e., PPI) more effectively prevents bleeding after the recent advanced technique of endoscopic submucosal dissection (ESD) for EGC. METHODS: This was a prospective randomized controlled trial performed in a referral cancer center. A total of 143 patients with EGC who underwent ESD were randomly assigned to the treatment groups. They received either rabeprazole 20 mg (PPI group) or cimetidine 800 mg (H₂RA group) on the day before ESD and continued for 8 wk. The primary end point was the incidence of bleeding that was defined as hematemesis or melena that required endoscopic hemostasis and decreased the hemoglobin count by more than 2 g/dL. RESULTS: In baseline data, the endoscopists who performed the ESD were significantly different between the groups. Finally, 66 of 73 patients in the PPI group and 64 of 70 in the H₂RA group were analyzed. Bleeding occurred in four patients in the PPI group and 11 in the H₂RA group (P = 0.057). Multivariate analysis revealed that treatment with the PPI significantly reduced the risk of bleeding: adjusted hazard ratio 0.47, 95% confidence interval 0.22-0.92, P = 0.028. One delayed perforation was experienced in the H₂RA group. CONCLUSIONS: PPI therapy more effectively prevented delayed bleeding from the ulcer created after ESD than did H₂RA treatment.