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

November 4, 2010
May 1, 2014
December 2010
March 2013   (final data collection date for primary outcome measure)
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.
Transplant-free Survival [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01236339 on ClinicalTrials.gov Archive Site
  • 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.
  • Overall Survival [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
  • Time to Transplant [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
  • Frequency of Large Volume Paracentesis [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
  • Frequency of Hepatic Encephalopathy [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
  • Change in MELD Score [ Time Frame: Baseline, Discharge (if applicable), 30 days, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline, 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Procedural Success [ Time Frame: Time of TIPS Procedure ] [ Designated as safety issue: No ]
  • Complications of Portal Hypertension [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Cirrhosis
  • Portal Hypertension
  • Ascites
  • Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
    TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
  • 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
  • Experimental: TIPS
    TIPS with GORE® VIATORR® TIPS Endoprosthesis
    Intervention: Device: 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).

    Interventions:
    • Procedure: LVP
    • Device: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
March 2013
March 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01236339
VTR 10-03
Yes
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: Thomas Boyer, MD University of Arizona College of Medicine
Principal Investigator: Ziv Haskal, MD University of Maryland
W.L.Gore & Associates
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP