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Clinical Trials/NCT00690027
NCT00690027CompletedNot Applicable

San Diego Bleeding Esophageal Varices Study

University of California, San Diego2 sites in 1 country211 target enrollmentStarted: June 4, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
211
Locations
2
Primary Endpoint
Survival
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Sex
All
Accepts 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

  • Not provided

Outcomes

Primary Outcomes

Survival

Time Frame: 10 years

Secondary Outcomes

  • Control of bleeding and quality of life(10 years)

Investigators

Sponsor Class
Other

Study Sites (2)

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