Clinical Trial: Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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,

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 Summary: 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.
Sponsor: Chinese University of Hong Kong

Current Primary Outcome: Recurrent bleeding [ Time Frame: Within 30 days ]

Original Primary Outcome:

  • Recurrent bleeding within 30 days
  • Blood transfusion requirements
  • Need for urgent/emergent ulcer surgery for bleeding
  • Need for angiographic treatment of bleeding
  • Death


Current Secondary Outcome:

  • Length of stay [ Time Frame: Within 56 days ]
  • ICU utilization [ Time Frame: Within 56 days ]
  • Blood Transfusion during hospital [ Time Frame: Within 56 days ]
  • Need for urgent/emergent ulcer surgery for bleeding [ Time Frame: Within 56 days ]
  • Need for angiographic treatment of bleeding [ Time Frame: Within 56 days ]
  • Death [ Time Frame: within 56 days ]


Original Secondary Outcome:

  • Lenght of stay
  • ICU utilization


Information By: Chinese University of Hong Kong

Dates:
Date Received: September 12, 2005
Date Started: September 2004
Date Completion:
Last Updated: August 27, 2012
Last Verified: August 2012