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TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis

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ClinicalTrials.gov Identifier: NCT00734227
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : August 14, 2008
Sponsor:
Information provided by:
University of California, San Diego

Brief 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.

Condition or disease Intervention/treatment Phase
Bleeding Procedure: Emergency portacaval shunt Other: Emergency TIPS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
Study Start Date : July 1996
Actual Primary Completion Date : October 2003
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Survival [ Time Frame: 10 years ]

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


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: July 2008

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes