Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage: Can it Guide the Use of and Predict Failure of Endoscopic Treatment? A Prospective, Multicenter, Randomized, Controlled Study

Conditions
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Peptic Ulcer Hemorrhage

Intervention / Treatment
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* Device: Doppler ultrasound probe


Participation Criteria
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Eligibility Criteria
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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: SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or, Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or, 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Doppler ultrasound<br> | Device: Doppler ultrasound probe<br>* Applying to ulcer base to assess the blood flow underneath the ulcer<br>* Other names: DOP_US;|
| No Intervention: No Doppler ultrasound<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent bleeding |  | Within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peptic ulcer hemorrhage, Doppler ultrasound