This multicenter prospective randomized clinical trial compares the surgical distal splenorenal shunt (DSRS) with the radiologic transjugular intrahepatic portal systemic shunt (TIPS) for variceal bleeding in good risk patients. The hypothesis to be tested is that TIPS will have a significantly higher rebleeding rate and encephalopathy incidence than DSRS. This study is entering its fifth year, and this renewal application will provide for a further 3 years of follow-up.
The specific aims are to enter 140 patients- 114 have been entered by 10/2000- with a minimum 2 years and median 5 years follow-up. The study population are patients with Child's Class A or B cirrhosis who have failed endoscopic and pharmacologic therapy for their variceal bleeding. Uncontrolled studies show a variceal rebleeding rate of 20% after TIPS compared to 5% after DSRS, and encephalopathy incidence of 30% after TIPS compared to 14% after DSRS. This trial is planned with sufficient power to detect a 15% difference in defined endpoints. The health related importance of this study is in defining the role of these two decompression therapies in terms of variceal bleeding control, change in liver function (encephalopathy, ascites, liver failure, need for transplant), mortality, quality of life and costs. Data collection and analysis of these endpoints constitute the goal of this application. This renewal application plans to extend this trial to allow the five Clinical Centers to complete patient recruitment and provide longer term follow-up and data collection on all randomized patients. The Data Coordinating Center is responsible for data verification, management and analysis. The extension of this trial, will provide the most comprehensive and longest follow-up for these two shunt procedures for control of variceal bleeding.
