Early TIPS for Ascites Study

The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension

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 Overview

• Status: Terminated
• Conditions: Liver Cirrhosis; Ascites; Portal Hypertension
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States
      • University of Arizona
  • Maryland
    • Baltimore, Maryland, United States
      • University of Maryland-Baltimore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIPS; TIPS with GORE® VIATORR® TIPS Endoprosthesis	Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis; TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
Active Comparator: 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).	Procedure: LVP; Large Volume Paracentesis; Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Through 24 months
Frequency of Paracentesis	Number of paracentesis post randomization	Through 24 months
Frequency of Hepatic Encephalopathy	Number of episodes of West Haven grade 2 or greater	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 of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)
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.	Through 24 months

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Thomas Boyer, MD, University of Arizona College of Medicine; Principal Investigator: Ziv Haskal, MD, University of Maryland

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: November 4, 2010
• First Submitted That Met QC Criteria: November 5, 2010
• First Posted (Estimate): November 8, 2010

Study Record Updates

• Last Update Posted (Estimate): June 3, 2014
• Last Update Submitted That Met QC Criteria: May 1, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Fibrosis; Hypertension; Liver Cirrhosis; Ascites; Hypertension, Portal
• Other Study ID Numbers: VTR 10-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No