Survival and Control of Bleeding
Conditions
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
Interventions
PROCEDUREEmergency portacaval shunt
PROCEDUREEmergency and long-term endoscopic sclerotherapy
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | 10 years |
Secondary
| Measure | Time frame |
|---|---|
| Control of bleeding and quality of life | 10 years |
Countries
United States
Outcome results
None listed