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NCT00734227 Clinical Trial

TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

Bleeding Clinical Trial

Official title:
TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00734227
Other study ID # TvSSTUDY
Secondary ID
Status Completed
Phase N/A
First received August 13, 2008
Last updated August 13, 2008
Start date July 1996
Est. completion date July 2006

Study information
Verified date July 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 acute portal hypertension-related bleeding to compare the effectiveness in control of bleeding, mortality rate, duration of life, quality of life, and economic costs of two widely used treatment measures: (1) emergency transjugular intrahepatic portal-systemic shunt (TIPS), and (2) emergency portacaval shunt.

Recruitment information / eligibility
Status Completed
Enrollment 153
Est. completion date July 2006
Est. primary completion date October 2003
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with UGI bleeding who are shown to have the findings of cirrhosis and esophagogastric varices or portal hypertensive gastropathy and require 2 or more units of blood transfusion will be included.

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Emergency portacaval shunt

Other:
• Emergency TIPS

Locations
Country Name City State
United States UCSD Medical Center 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
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