Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

August 27, 2012 updated by: James Yun-wong Lau, Chinese University of Hong Kong

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

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.

Study Overview

Status

Terminated

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong SAR, China
        • Endoscopy Center, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Doppler ultrasound
Applying to ulcer base to assess the blood flow underneath the ulcer
Other Names:
  • DOP_US
No Intervention: No Doppler ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrent bleeding
Time Frame: Within 30 days
Within 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

August 28, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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