TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
|ClinicalTrials.gov Identifier: NCT00734227|
Recruitment Status : Completed
First Posted : August 14, 2008
Last Update Posted : August 14, 2008
|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|
|Intervention Model:||Parallel Assignment|
|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|
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|
- Survival [ Time Frame: 10 years ]
- Control of bleeding and quality of life [ Time Frame: 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734227
|United States, California|
|UCSD Medical Center|
|San Diego, California, United States, 92103|
|Principal Investigator:||Marshall J. Orloff, M.D.||UCSD Medical Center|