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A Prospective Randomized Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer
This study is currently recruiting participants.
Verified by Chinese University of Hong Kong, September 2005
First Received: September 11, 2005   Last Updated: November 16, 2005   History of Changes
Sponsored by: Chinese University of Hong Kong
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00164931
  Purpose

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.


Condition Intervention Phase
Peptic Ulcer Hemorrhage
Drug: Intravenous omeprazole infusion
Procedure: Scheduled second endoscopy
Phase III

MedlinePlus related topics: Blood Transfusion and Donation Endoscopy Peptic Ulcer Surgery
Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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:
  • 1. The rate of surgery
  • 2. Mortality
  • 3. Length of Hospital stay
  • 4. Transfusion

Estimated Enrollment: 240
Study Start Date: October 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00164931

Contacts
Contact: Philip WY Chiu, MBChB, FRCSEd 26322627 pwychiu@netvigator.com
Contact: Henry KM Joeng, MBBS 35134000 henryjoeng@misdc.org

Locations
China
Department of Surgery, United Christian Hospital Recruiting
Hong Kong, China
Contact: Philip WY Chiu, MBChB, FRCSEd     26322627     pwychiu@netvigator.com    
Contact: Henry KM Joeng, MBBS     35134000     henryjoeng@misdc.org    
Sub-Investigator: Catherine LY Choi, MBBS            
Sub-Investigator: Kwok Hung Kwong, MBChB, FRCSEd            
Sub-Investigator: Siu Ho Lam, MBBS, FRCSEd            
Sponsors and Collaborators
Chinese University of Hong Kong
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
  More Information

No publications provided

Study ID Numbers: UCHCE03-43-SURG5
Study First Received: September 11, 2005
Last Updated: November 16, 2005
ClinicalTrials.gov Identifier: NCT00164931     History of Changes
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Peptic ulcer hemorrhage
Omeprazole
Scheduled second endoscopy

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Peptic Ulcer Hemorrhage
Gastrointestinal Hemorrhage
Omeprazole
Intestinal Diseases
Hemorrhage
Duodenal Diseases
Peptic Ulcer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Ulcer
Gastrointestinal Agents
Gastrointestinal Hemorrhage
Omeprazole
Enzyme Inhibitors
Hemorrhage
Intestinal Diseases
Pharmacologic Actions
Pathologic Processes
Digestive System Diseases
Stomach Diseases
Therapeutic Uses
Peptic Ulcer Hemorrhage
Anti-Ulcer Agents
Peptic Ulcer
Duodenal Diseases

ClinicalTrials.gov processed this record on May 06, 2009