Comparison of Proton Pump Inhibitor with H2 Receptor Antagonist for Prevention of Bleeding from Ulcer After Endoscopic Submucosal Dissection for Early Gastric Cancers: A Non-Blind Randomized Controlled Trial

Abstract

Background: Proton pump inhibitor (PPI) and H2 receptor antagonist (H2RA) have similar effect on prevention of bleeding after endoscopic mucosal resection (EMR) for early gastric cancer (EGC) by conventional strip biopsy method. Introduction of wide spread EMR by endoscopic submucosal dissection (ESD) technique caused higher rate of bleeding after procedure than the conventional methods in our center. Objective: To evaluate preventive effects of PPI and H2RA on bleeding from ulcer after EMR by ESD. Design: A non-blind randomized controlled trial. Setting: Endoscopy unit at a cancer center. Patients: A total of 105 patients (84 men and 21 women, mean age 67 years old) with EGC treated by ESD technique between January and November 2005. Median (range) tumor size was 15 (5-105) mm. Patients having administration of anticoagulant and severe organ failure were excluded. Written informed consent was obtainted from all patients and the study protocol was approved by the institutional review board. Interventions: Patients were randomized to two groups; labeprazole 40 mg p.o. bid (PPI group) from one day before procedure, and cimetidine 800 mg div two days followed by cimetidine 800 mg p.o. bid (H2RA group). Treatments were continued for 8 weeks. Main outcome measurements: Bleeding that was defined as hematoemesis and melena required endoscopic hemostasis, and decreased Hb of less than 2 mg/dl. Results: Significant differences were not available in age, sex, history of peptic ulcer, status of Helicobacter pylori, mean tumor size, and location of the tumor between the groups. Bleeding rate of the PPI group (1.8%; 1/55) was significantly less than that in the H2RA group (12%; 6/50, p = 0.043). Late perforation was occured in two patients in the H2RA group. Limitations: Non-blind design and a relatively small number of subjects. Conclusion: PPI inhibits bleeding from ulcer and the adverse effect after ESD for EGC.