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Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

NCT ID: NCT00164905

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-08-31

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.

Conditions

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Peptic Ulcer Hemorrhage

Keywords

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Peptic ulcer hemorrhage Doppler ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Doppler ultrasound

Group Type ACTIVE_COMPARATOR

Doppler ultrasound probe

Intervention Type DEVICE

Applying to ulcer base to assess the blood flow underneath the ulcer

No Doppler ultrasound

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Doppler ultrasound probe

Applying to ulcer base to assess the blood flow underneath the ulcer

Intervention Type DEVICE

Other Intervention Names

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DOP_US

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:

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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James Yun-wong Lau

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Y Lau, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital

Locations

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Endoscopy Center, Prince of Wales Hospital

Hong Kong SAR, , China

Site Status

Countries

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China

Other Identifiers

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DOP-US study

Identifier Type: -

Identifier Source: org_study_id