San Diego Bleeding Esophageal Varices Study
- Conditions
- Survival and Control of Bleeding
- Registration Number
- NCT00690027
- Lead Sponsor
- University of California, San Diego
- Brief Summary
In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:
* Emergency portacaval shunt, and
* Emergency and long-term endoscopic sclerotherapy.
- Detailed Description
See attached Synopsis - APPENDIX 1
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
-
All patients with UGI bleeding (blood in the esophagus, stomach, or duodenum) who enter the emergency room or develop bleeding while in the hospital or are transferred from nearby hospitals and are suspected of having cirrhosis and BEV will be eligible for consideration (all comers).
-
Those who are shown to have the findings of cirrhosis and esophageal varices that:
- Are seen to be actively bleeding;
- Have an adherent clot;
- Have no other associated lesion that could reasonably account for bleeding of that magnitude (such as large gastric or duodenal varices, GU, DU, etc)
-
Require 2 or more units of blood transfusion, will be included in the study.
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Survival 10 years
- Secondary Outcome Measures
Name Time Method Control of bleeding and quality of life 10 years
Trial Locations
- Locations (1)
200 West Arbor Drive
🇺🇸San Diego, California, United States
200 West Arbor Drive🇺🇸San Diego, California, United States