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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Endos

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Chinese University of Hong Kong

Current Primary Outcome:

  • Recurrent bleeding within 30 days after initial endoscopy defined as -
  • Clinical criteria (anyone of the below)
  • 1. Haemetmesis or fresh blood from Ryles tube
  • 2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl
  • 3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy
  • 4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs
  • AND Endoscopic criteria of Forrest I a, b or II a, b


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 1. The rate of surgery
  • 2. Mortality
  • 3. Length of Hospital stay
  • 4. Transfusion


Original Secondary Outcome: Same as current

Information By: Chinese University of Hong Kong

Dates:
Date Received: September 11, 2005
Date Started: October 2003
Date Completion:
Last Updated: June 9, 2011
Last Verified: September 2005