High‐Dose Oral Omeprazole Versus Continuous Intravenous Pantoprazole in Patients With High‐Risk Peptic Ulcer Bleeding: A Single‐Blinded Multicenter RCT

BACKGROUND AND AIM: The efficacy of high-dose oral omeprazole in peptic ulcer bleeding after successful therapeutic hemostatic endoscopy has not been well established. This study aimed to compare the efficacy of high-dose oral omeprazole versus continuous intravenous (IV) pantoprazole in rebleeding and percent time of gastric pH above 6. METHODS: Eligible patients were randomized with 1:1 concealed allocation to 40-mg oral omeprazole twice daily or IV pantoprazole 8 mg/h for 72 h after index gastroscopy. Gastric pH was measured for 24 h during 48-72 h after starting the assigned medication. Rebleeding at 72 h and 30 days, as well as 24-h gastric pH, were assessed. RESULTS: A total of 124 patients were analyzed. Seventy-two-hour rebleeding occurred in 1.6% (1/61) of the oral omeprazole group and 4.8% (3/63) of the IV pantoprazole group requiring endoscopic hemostasis (risk difference [RD] -3.1%, 95% CI -11.6% to 4.6%). Rebleeding within 30 days also showed no difference between groups (3.3% vs. 4.8%, RD -1.5%, 95% CI -10.1% to 7.0%). Gastric pH monitoring was completed in 48% (29/61) of the oral group and 41% (26/63) of the IV group. The median percentage of gastric pH > 6 was 56.3% (IQR 28.0%-92.0%) in the oral group and 27.3% (IQR 4.4%-77.7%) in the IV group (p = 0.064). CONCLUSIONS: High-dose oral omeprazole may represent a feasible alternative to continuous IV pantoprazole in terms of preventing rebleeding at 72 h and 30 days and maintaining gastric pH > 6 among patients with peptic ulcer bleeding who underwent successful therapeutic hemostatic endoscopy. TRIAL REGISTRATION: Registration number: NCT04394663.