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NCT Number: NCT00164931

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Surgery, United Christian Hospital

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous omeprazole infusion

Drug

Scheduled second endoscopy

Procedure

Primary outcomes

  1. Recurrent bleeding within 30 days after initial endoscopy defined as -

  2. Clinical criteria (anyone of the below)

  3. 1. Haemetmesis or fresh blood from Ryles tube

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

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

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

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

Secondary outcomes

  1. 1. The rate of surgery

  2. 2. Mortality

  3. 3. Length of Hospital stay

  4. 4. Transfusion

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2003
First posted
Sep 14, 2005
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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