First Patient Enrolled in Gore Early TIPS for Ascites Study

April 25, 2011—Gore & Associates (Flagstaff, AZ) announced the commencement of enrollment in the Early TIPS for Ascites Study with the first patient treated at Indiana University Hospital in Indianapolis.

According to the company, the objective of this prospective, randomized, multicenter clinical study is to evaluate whether the transjugular intrahepatic portosystemic shunt (TIPS) procedure with the Gore Viatorr TIPS endoprosthesis improves transplant-free survival when compared to large-volume paracentesis in patients with cirrhosis of the liver and difficult to treat ascites.

Gore stated that the study is a large and rigorous multidisciplinary collaboration with hepatologists and interventional radiologists evaluating early TIPS therapy with 150 subjects enrolled at approximately 20 sites. At Indiana University Hospital, the study is being led by hepatologist Raj Vuppalanchi, MD, and interventional radiologist David Agarwal, MD. 

“Indiana University Hospital is pleased to be the first facility to treat a patient in this important study aimed at prolonging the lives of patients and providing more than just a bridge to transplant,” commented Drs. Vuppalanchi and Agarwal. “The possibility exists that we may reduce the need for alternative treatments such as medication and paracentesis; potentially improving the quality of lives for those with liver disease as well.”


 The company announced the plans for the trial in November 2010, as was reported in Endovascular Today. More information about the Early TIPS for Ascites Study is available on Gore's Web site.

“Most treatments for complications of portal hypertension improve the patient's condition without an impact on survival,” stated Thomas Boyer, MD, national principal investigator for the Gore clinical study. “We believe in this new TIPS study for early resistant ascites and that an improvement in survival will be seen.”