Clinical trial NCT00164931: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peptic Ulcer Hemorrhage
Keywords: Peptic ulcer hemorrhage
Omeprazole
Scheduled second endoscopy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Recurrent bleeding within 30 days after initial endoscopy defined as -
measure: Clinical criteria (anyone of the below)
measure: 1. Haemetmesis or fresh blood from Ryles tube
measure: 2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl
measure: 3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy
measure: 4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs
measure: AND Endoscopic criteria of Forrest I a, b or II a, b
Secondary outcomes:
measure: 1. The rate of surgery
measure: 2. Mortality
measure: 3. Length of Hospital stay
measure: 4. Transfusion
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, United Christian Hospital
Study officials:
affiliation: Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
name: Philip WY Chiu, MBChB, FRCSEd
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, United Christian Hospital, Hong Kong
name: Henry KM Joeng, MBBS
role: PRINCIPAL_INVESTIGATOR
References: