Early TIPS for Ascites Study

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01236339
First received: November 4, 2010
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Liver Cirrhosis
Portal Hypertension
Ascites
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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Transplant-free Survival [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]

    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:
  • Overall Survival [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
    Number of paracentesis post randomization

  • Frequency of Hepatic Encephalopathy [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
    Number of episodes of West Haven grade 2 or greater

  • Procedural Success [ 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) ] [ Designated as safety issue: No ]

    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) [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: December 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236339

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States
United States, Maryland
University of Maryland-Baltimore
Baltimore, Maryland, United States
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Thomas Boyer, MD University of Arizona College of Medicine
Principal Investigator: Ziv Haskal, MD University of Maryland
  More Information

Additional Information:
No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01236339     History of Changes
Other Study ID Numbers: VTR 10-03
Study First Received: November 4, 2010
Results First Received: January 31, 2014
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ascites
Hypertension
Hypertension, Portal
Liver Cirrhosis
Cardiovascular Diseases
Digestive System Diseases
Liver Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014