Survival and Control of Bleeding Clinical Trial
Official title:
San Diego Bleeding Esophageal Varices Study
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.
| Status | Completed |
| Enrollment | 211 |
| Est. completion date | December 2005 |
| Est. primary completion date | August 1996 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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: |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | 200 West Arbor Drive | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, San Diego |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Survival | 10 years | ||
| Secondary | Control of bleeding and quality of life | 10 years |