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TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00734227
First received: August 13, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Bleeding
 Procedure: Emergency portacaval shunt
Other: Emergency TIPS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Survival [ Time Frame: 10 years ]

Secondary Outcome Measures:
  • Control of bleeding and quality of life [ Time Frame: 10 years ]

Enrollment: 153
Study Start Date: July 1996
Study Completion Date: July 2006
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A

Randomization: By the blind card method to TIPS or emergency portacaval shunt. Diagnostic Workup: Completed within 6hr. Rapidity of Therapy: Within 24 hr. Failure of Therapy: Bleeding requiring >6u PRBC in first 7 days, or 8 units PRBC during 12 months.

Rescue Crossover Therapy: When primary therapy has failed. Followup: Lifelong data collection on line, analysis by biostatistician Florin Vaida, PhD. External Advisory, Data Monitoring and Safety Committee by 3 senior academicians.

Procedure: Emergency portacaval shunt.

 Procedure: Emergency portacaval shunt
Active Comparator: B
Procedure: Emergency TIPS.
 Other: Emergency TIPS

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734227

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Marshall J. Orloff, M.D. UCSD Medical Center
  More Information

No publications provided by University of California, San Diego

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marshall J. Orloff, M.D., University of California, San Diego
ClinicalTrials.gov Identifier: NCT00734227     History of Changes
Other Study ID Numbers: TvSSTUDY
Study First Received: August 13, 2008
Last Updated: August 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Survival and control of hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Fibrosis
Varicose Veins
 Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013