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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00690027
Other study ID # ESTVEPCS
Secondary ID
Status Completed
Phase N/A
First received June 3, 2008
Last updated June 3, 2008
Start date April 1988
Est. completion date December 2005

Study information

Verified date June 2008
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

See attached Synopsis - APPENDIX 1


Recruitment information / eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

Procedure:
Emergency portacaval shunt

Emergency and long-term endoscopic sclerotherapy


Locations

Country Name City State
United States 200 West Arbor Drive San Diego California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival 10 years
Secondary Control of bleeding and quality of life 10 years