A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer

Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endoscopy

A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.

We have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding. We found that the rate of recurrent bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis.

When we look at the studies in the literature employing proton pump inhibitors (PPI) infusion after primary endoscopic therapy, we found that there was also a significant reduction in the rate of rebleeding, the number of operation performed and the transfusion requirement.

Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis. A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding.

We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers.

Inclusion Criteria:

• all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb
• age 15 - 90 years
• Written consent available

Exclusion Criteria:

• ulcer bleeding not controlled in first endoscopy
• Bleeding from malignant ulcer or tumor
• Bleeding from Dieulafoy lesion/ angiodysplasia
• Bleeding from injection sclerotherapy ulcer
• Patient with ASA category 5