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Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborator:
University Hospitals of Cleveland
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00164905
First received: September 12, 2005
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Peptic Ulcer Hemorrhage
 Device: Doppler ultrasound probe

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Recurrent bleeding [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of stay [ Time Frame: Within 56 days ] [ Designated as safety issue: No ]
  • ICU utilization [ Time Frame: Within 56 days ] [ Designated as safety issue: No ]
  • Blood Transfusion during hospital [ Time Frame: Within 56 days ] [ Designated as safety issue: No ]
  • Need for urgent/emergent ulcer surgery for bleeding [ Time Frame: Within 56 days ] [ Designated as safety issue: No ]
  • Need for angiographic treatment of bleeding [ Time Frame: Within 56 days ] [ Designated as safety issue: No ]
  • Death [ Time Frame: within 56 days ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: September 2004
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Doppler ultrasound Device: Doppler ultrasound probe
Applying to ulcer base to assess the blood flow underneath the ulcer
Other Name: DOP_US
No Intervention: No Doppler ultrasound

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00164905

Locations
China
Endoscopy Center, Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
University Hospitals of Cleveland
Investigators
Principal Investigator: James Y Lau, MD Prince of Wales Hospital
  More Information

No publications provided

Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00164905     History of Changes
Other Study ID Numbers: DOP-US study
Study First Received: September 12, 2005
Last Updated: August 27, 2012
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Peptic ulcer hemorrhage
Doppler ultrasound

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage

ClinicalTrials.gov processed this record on June 17, 2013