The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
Large Volume Paracentesis
University of Arizona
Tucson, Arizona, United States
University of Maryland-Baltimore
Baltimore, Maryland, United States
Transplant-free Survival
Time from randomization to death from any cause prior to transplant. Subjects who undergo liver transplant will be censored at the time of transplant. Subjects without an event will be censored at the date of last follow-up. * Note: The outcome entered below is the number of participants who were either alive or had a liver transplant at time of study termination.
Time frame: Through 24 months
Overall Survival
Time from randomization to death from any cause. Subjects without an event will be censored at the date of last follow-up. \> \*Note: Outcome measure entered below is number of subjects alive at time of study termination.
Time frame: Through 24 months
Time to Transplant
Time from randomization to transplant. Subjects without an event will be censored at the date of last follow-up or date of death without transplant. \*Note: Outcome measure entered is number of subjects who received a liver transplant at time of study termination.
Time frame: Through 24 months
Frequency of Paracentesis
Number of paracentesis post randomization
Time frame: Through 24 months
Frequency of Hepatic Encephalopathy
Number of episodes of West Haven grade 2 or greater
Time frame: Through 24 months
Procedural Success
Successful creation of a VIATORR(R) device lined portosystemic shunt spanning a hepatic vein and intrahepatic branch of the portal vein \*Note: Control (LVP) arm includes only subjects who crossed over to TIPS
Time frame: Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)
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Liver Disease Complications (Adverse Events)
Overall frequency and component frequencies. Complications will include hepatic encephalopathy, hepatic hydrothorax, hepatoma, hepatorenal syndrome (Type 1 or Type 2), hyponatremia (\<130mEq / L), spontaneous bacterial peritonitis, and variceal bleeding.
Time frame: Through 24 months