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

Primary Purpose

Peptic Ulcer Hemorrhage

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Intravenous omeprazole infusion

Scheduled second endoscopy

About this trial

This is an interventional treatment trial for Peptic Ulcer Hemorrhage focused on measuring Peptic ulcer hemorrhage, Omeprazole, Scheduled second endoscopy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Surgery, United Christian Hospital

Outcomes

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

Full Information

NCT ID

NCT00164931

First Posted

September 11, 2005

Last Updated

June 9, 2011

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00164931

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peptic Ulcer Hemorrhage

Keywords

Peptic ulcer hemorrhage, Omeprazole, Scheduled second endoscopy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Intravenous omeprazole infusion

Intervention Type

Procedure

Intervention Name(s)

Scheduled second endoscopy

Primary Outcome Measure Information:

Title

Recurrent bleeding within 30 days after initial endoscopy defined as -

Title

Clinical criteria (anyone of the below)

Title

1. Haemetmesis or fresh blood from Ryles tube

Title

2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl

Title

3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy

Title

4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs

Title

AND Endoscopic criteria of Forrest I a, b or II a, b

Secondary Outcome Measure Information:

Title

1. The rate of surgery

Title

2. Mortality

Title

3. Length of Hospital stay

Title

4. Transfusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip WY Chiu, MBChB, FRCSEd

Organizational Affiliation

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Henry KM Joeng, MBBS

Organizational Affiliation

Department of Surgery, United Christian Hospital, Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Surgery, United Christian Hospital

City

Hong Kong

Country

China

12. IPD Sharing Statement

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

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