Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

Not Applicable

Terminated

• Conditions: Peptic Ulcer Hemorrhage
• Interventions: Device: Doppler ultrasound probe

• Registration Number: NCT00164905
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.

Detailed Description

Bleeding peptic ulcer is a life-threatening emergency. Endoscopic therapy is a proven technique in the acute hemostasis of bleeding ulcers. Currently there is no objective assessment of adequacy of endoscopic therapy. Endoscopic Doppler ultrasound enables endoscopists in detecting blood flow in a vessel beneath an ulcer. A persistent signal after endoscopic therapy predicts recurrent bleeding. The current study proposes to compare assessment of ulcer base using either Doppler ultrasound or endoscopists' interpretation of ulcer floors. The trial design is one of a prospective randomized controlled cross-over study in which patients with severe upper gastrointestinal bleeding and documented peptic ulcers at endoscopy are enrolled.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following:

  1. SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or,
  2. Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or,
  3. A documented HCT drop of at lest 6% from baseline.

• Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer

• Pt can either have primary or secondary acute UGI haemorrhage

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Exclusion Criteria

• Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer
• there is more than one type of significant bleeding lesion
• Documented hx of cirrhosis / portal HT
• ESRF requiring any form of dialysis
• Expected or persistent (>24hrs) coagulopathy with INR> 1.5
• Platelet count is under 50000/mm3
• Aspirin User / Plavix [Clopidogrel] User
• If the ulcer is neoplastic
• Cannot obtained consent
• Age < 18 or is pregnant
• Severe comorbid of which life expectancy <30 days

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doppler ultrasound	Doppler ultrasound probe	-

Primary Outcome Measures

Name	Time	Method
Recurrent bleeding	Within 30 days

Secondary Outcome Measures

Name	Time	Method
Length of stay	Within 56 days
ICU utilization	Within 56 days
Blood Transfusion during hospital	Within 56 days
Need for urgent/emergent ulcer surgery for bleeding	Within 56 days
Need for angiographic treatment of bleeding	Within 56 days
Death	within 56 days

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong SAR, China