Clinical trial NCT00164905: 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
Overall status: TERMINATED
Phase: NA
Conditions: Peptic Ulcer Hemorrhage
Keywords: Peptic ulcer hemorrhage
Doppler ultrasound
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2005-09-14
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Recurrent bleeding
timeFrame: Within 30 days
Secondary outcomes:
measure: Length of stay
timeFrame: Within 56 days
measure: ICU utilization
timeFrame: Within 56 days
measure: Blood Transfusion during hospital
timeFrame: Within 56 days
measure: Need for urgent/emergent ulcer surgery for bleeding
timeFrame: Within 56 days
measure: Need for angiographic treatment of bleeding
timeFrame: Within 56 days
measure: Death
timeFrame: within 56 days
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Prince of Wales Hospital
name: James Y Lau, MD
role: PRINCIPAL_INVESTIGATOR
References: