- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164931
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Hong Kong, China
- Department of Surgery, United Christian Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Recurrent bleeding within 30 days after initial endoscopy defined as -
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Clinical criteria (anyone of the below)
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1. Haemetmesis or fresh blood from Ryles tube
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2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl
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3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy
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4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs
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AND Endoscopic criteria of Forrest I a, b or II a, b
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Secondary Outcome Measures
Outcome Measure |
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1. The rate of surgery
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2. Mortality
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3. Length of Hospital stay
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4. Transfusion
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philip WY Chiu, MBChB, FRCSEd, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
- Principal Investigator: Henry KM Joeng, MBBS, Department of Surgery, United Christian Hospital, Hong Kong
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Duodenal Diseases
- Gastrointestinal Hemorrhage
- Ulcer
- Hemorrhage
- Peptic Ulcer
- Peptic Ulcer Hemorrhage
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Omeprazole
Other Study ID Numbers
- UCHCE03-43-SURG5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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