Peptic Ulcer Hemorrhage
Conditions
Keywords
Peptic ulcer hemorrhage, Doppler ultrasound
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.
Interventions
DEVICEDoppler ultrasound probe
Applying to ulcer base to assess the blood flow underneath the ulcer
Sponsors
University Hospitals Cleveland Medical Center
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent bleeding | Within 30 days |
Secondary
| Measure | Time frame |
|---|---|
| ICU utilization | Within 56 days |
| Blood Transfusion during hospital | Within 56 days |
| Length of stay | Within 56 days |
| Need for angiographic treatment of bleeding | Within 56 days |
| Death | within 56 days |
| Need for urgent/emergent ulcer surgery for bleeding | Within 56 days |
Countries
China
Outcome results
None listed