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Early TIPS for Ascites Study

Primary Purpose

Liver Cirrhosis, Portal Hypertension, Ascites

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
LVP
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona
  • University of Maryland-Baltimore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIPS

LVP

Arm Description

TIPS with GORE® VIATORR® TIPS Endoprosthesis

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.
Frequency of Paracentesis
Number of paracentesis post randomization
Frequency of Hepatic Encephalopathy
Number of episodes of West Haven grade 2 or greater
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
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.

Full Information

First Posted
November 4, 2010
Last Updated
May 1, 2014
Sponsor
W.L.Gore & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT01236339
Brief Title
Early TIPS for Ascites Study
Official Title
The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Portal Hypertension, Ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIPS
Arm Type
Experimental
Arm Description
TIPS with GORE® VIATORR® TIPS Endoprosthesis
Arm Title
LVP
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
Intervention Description
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
Intervention Type
Procedure
Intervention Name(s)
LVP
Intervention Description
Large Volume Paracentesis
Intervention Type
Device
Intervention Name(s)
TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol
Primary Outcome Measure Information:
Title
Transplant-free Survival
Description
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
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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
Title
Time to Transplant
Description
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
Title
Frequency of Paracentesis
Description
Number of paracentesis post randomization
Time Frame
Through 24 months
Title
Frequency of Hepatic Encephalopathy
Description
Number of episodes of West Haven grade 2 or greater
Time Frame
Through 24 months
Title
Procedural Success
Description
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)
Title
Liver Disease Complications (Adverse Events)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Boyer, MD
Organizational Affiliation
University of Arizona College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ziv Haskal, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
University of Maryland-Baltimore
City
Baltimore
State/Province
Maryland
Country
United States

12. IPD Sharing Statement

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Early TIPS for Ascites Study

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