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

September 12, 2005
August 27, 2012
September 2004
August 2010   (final data collection date for primary outcome measure)
Recurrent bleeding [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
  • Recurrent bleeding within 30 days
  • Blood transfusion requirements
  • Need for urgent/emergent ulcer surgery for bleeding
  • Need for angiographic treatment of bleeding
  • Death
Complete list of historical versions of study NCT00164905 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Lenght of stay
  • ICU utilization
Not Provided
Not Provided
 
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Peptic Ulcer Hemorrhage
Device: Doppler ultrasound probe
Applying to ulcer base to assess the blood flow underneath the ulcer
Other Name: DOP_US
  • Active Comparator: Doppler ultrasound
    Intervention: Device: Doppler ultrasound probe
  • No Intervention: No Doppler ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
121
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00164905
DOP-US study
No
James Yun-wong Lau, Chinese University of Hong Kong
Chinese University of Hong Kong
University Hospitals of Cleveland
Principal Investigator: James Y Lau, MD Prince of Wales Hospital
Chinese University of Hong Kong
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP