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

Peptic Ulcer Hemorrhage Clinical Trial

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 Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164931
• Other study ID #: UCHCE03-43-SURG5
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2005
• Last updated: June 9, 2011
• Start date: October 2003

Study information

• Verified date: September 2005
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Drug:
• Intravenous omeprazole infusion

Procedure:
• Scheduled second endoscopy

Locations

Country	Name	City	State
China	Department of Surgery, United Christian Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

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