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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK050680-09
Application #
6793199
Study Section
Special Emphasis Panel (ZDK1-GRB-7 (M5))
Program Officer
Robuck, Patricia R
Project Start
1996-09-01
Project End
2008-08-31
Budget Start
2004-09-01
Budget End
2008-08-31
Support Year
9
Fiscal Year
2004
Total Cost
$229,214
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Surgery
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
Boyer, Thomas D; Henderson, J Michael; Heerey, Adrienne M et al. (2008) Cost of preventing variceal rebleeding with transjugular intrahepatic portal systemic shunt and distal splenorenal shunt. J Hepatol 48:407-14
Lucey, Michael R; Connor, Jason T; Boyer, Thomas D et al. (2008) Alcohol consumption by cirrhotic subjects: patterns of use and effects on liver function. Am J Gastroenterol 103:1698-706
Henderson, J Michael; Boyer, Thomas D; Kutner, Michael H et al. (2006) Distal splenorenal shunt versus transjugular intrahepatic portal systematic shunt for variceal bleeding: a randomized trial. Gastroenterology 130:1643-51
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Chalasani, N; Imperiale, T F; Ismail, A et al. (1999) Predictors of large esophageal varices in patients with cirrhosis. Am J Gastroenterol 94:3285-91
Boyer, T D (1997) Natural history of portal hypertension. Clin Liver Dis 1:31-44, x