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

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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

Conditions
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Peptic Ulcer Hemorrhage

Intervention / Treatment
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* Drug: Intravenous omeprazole infusion
* Procedure: Scheduled second endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravenous omeprazole infusion|nan|
|Procedure: Scheduled second endoscopy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. The rate of surgery |  |  | 
| 2. Mortality |  |  | 
| 3. Length of Hospital stay |  |  | 
| 4. Transfusion |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peptic ulcer hemorrhage, Omeprazole, Scheduled second endoscopy