Early TIPS for Ascites Study

Not Applicable

Terminated

• Conditions: Liver Cirrhosis; Portal Hypertension; Ascites
• Interventions: Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis; Procedure: LVP; Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol

• Registration Number: NCT01236339
• Lead Sponsor: W.L.Gore & Associates

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-05
• Study First Posted: 2010-11-08
• Study Start: 2010-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2014-01-31
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-01
• Last Update Submitted: 2014-05-01
• Results First Posted: 2014-06-03
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

> Patient has cirrhosis of the liver with portal hypertension

> Patient has difficult to treat ascites

> Patient is 18 years or older and <70 years old at randomization

> Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.

> Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.

Exclusion Criteria

> Patient has more than 6 large volume paracenteses within 90 days prior to randomization

> Patient is contraindicated for TIPS placement

> Patient has had previous TIPS placement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIPS	TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis	TIPS with GORE® VIATORR® TIPS Endoprosthesis
LVP	LVP	Large Volume Paracentesis \*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure).
LVP	TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol	Large Volume Paracentesis \*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure).

Primary Outcome Measures

Name	Time	Method
Transplant-free Survival	Through 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Through 24 months	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 to Transplant	Through 24 months	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.
Frequency of Paracentesis	Through 24 months	Number of paracentesis post randomization
Frequency of Hepatic Encephalopathy	Through 24 months	Number of episodes of West Haven grade 2 or greater
Procedural Success	Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)	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
Liver Disease Complications (Adverse Events)	Through 24 months	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.

Trial Locations

Locations (2)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Maryland-Baltimore; 🇺🇸 Baltimore, Maryland, United States