The trial will compare selective decompression of varices by Distal Splenorenal Shunt (DSRS) to the radiologic decompression of varices by Transjugular Intrahepatic Portalsystemic Shunt (TIPS) in patients who have failed endoscopic and pharmacologic therapy for their variceal bleeding or are poor candidates for medical management. Patients with Childs Class A or B cirrhosis are eligible. After full evaluation, randomization will be to either DSRS or TIPS. The study will run over five years with a minimum of a two year follow-up. The primary endpoints are variceal rebleeding and encephalopathy. Secondary endpoints are death, need for liver transplant, ascites, deteriorating liver function, cost, and quality of life.
The five Recruitment Centers and their Principal Investigators are:
There are advantages and disadvantages of both procedures. Neither
procedure has been proven to be a better treatment for long-term control
of bleeding or for the overall management of patients with cirrhosis
and portal hypertension. A study directly comparing both procedures is now
being funded by the National Institutes of Health (NIH). This study is
being conducted at several medical facilities.
If endoscopic therapy and medications are no longer controlling your bleeding, you are a candidate for this study. We encourage you to participate. For more information about participating in this study please contact us.