TIPS Versus Portacaval Shunt for Acute Bleeding Varices in Cirrhosis
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.
|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|
- Survival [ Time Frame: 10 years ]
- Control of bleeding and quality of life [ Time Frame: 10 years ]
|Study Start Date:||July 1996|
|Study Completion Date:||July 2006|
|Primary Completion Date:||October 2003 (Final data collection date for primary outcome measure)|
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|
|United States, California|
|UCSD Medical Center|
|San Diego, California, United States, 92103|
|Principal Investigator:||Marshall J. Orloff, M.D.||UCSD Medical Center|