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Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

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ClinicalTrials.gov Identifier: NCT00164905
Recruitment Status : Terminated (Slow recruitment)
First Posted : September 14, 2005
Last Update Posted : August 28, 2012
Sponsor:
Collaborator:
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Device: Doppler ultrasound probe Not Applicable

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  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2004
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Recurrent bleeding [ Time Frame: Within 30 days ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: Within 56 days ]
  2. ICU utilization [ Time Frame: Within 56 days ]
  3. Blood Transfusion during hospital [ Time Frame: Within 56 days ]
  4. Need for urgent/emergent ulcer surgery for bleeding [ Time Frame: Within 56 days ]
  5. Need for angiographic treatment of bleeding [ Time Frame: Within 56 days ]
  6. Death [ Time Frame: within 56 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164905


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

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
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: August 28, 2012
Last Verified: August 2012

Keywords provided by James Yun-wong Lau, Chinese University of Hong Kong:
Peptic ulcer hemorrhage
Doppler ultrasound

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