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Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

Primary Purpose

Peptic Ulcer Hemorrhage

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Doppler ultrasound probe
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer Hemorrhage focused on measuring Peptic ulcer hemorrhage, Doppler ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endoscopy Center, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Doppler ultrasound

No Doppler ultrasound

Arm Description

Outcomes

Primary Outcome Measures

Recurrent bleeding

Secondary Outcome Measures

Length of stay
ICU utilization
Blood Transfusion during hospital
Need for urgent/emergent ulcer surgery for bleeding
Need for angiographic treatment of bleeding
Death

Full Information

First Posted
September 12, 2005
Last Updated
August 27, 2012
Sponsor
Chinese University of Hong Kong
Collaborators
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00164905
Brief Title
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Hemorrhage
Keywords
Peptic ulcer hemorrhage, Doppler ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doppler ultrasound
Arm Type
Active Comparator
Arm Title
No Doppler ultrasound
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Doppler ultrasound probe
Other Intervention Name(s)
DOP_US
Intervention Description
Applying to ulcer base to assess the blood flow underneath the ulcer
Primary Outcome Measure Information:
Title
Recurrent bleeding
Time Frame
Within 30 days
Secondary Outcome Measure Information:
Title
Length of stay
Time Frame
Within 56 days
Title
ICU utilization
Time Frame
Within 56 days
Title
Blood Transfusion during hospital
Time Frame
Within 56 days
Title
Need for urgent/emergent ulcer surgery for bleeding
Time Frame
Within 56 days
Title
Need for angiographic treatment of bleeding
Time Frame
Within 56 days
Title
Death
Time Frame
within 56 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Y Lau, MD
Organizational Affiliation
Prince of Wales Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Center, Prince of Wales Hospital
City
Hong Kong SAR
Country
China

12. IPD Sharing Statement

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Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

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