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: March 20, 2013
Last verified: March 2013
  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

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 ]

Secondary Outcome Measures:
  • 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 and Volume of 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 ]
  • Change in 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 ]
  • Liver Disease Complications (Adverse Events) [ Time Frame: Through 24 months ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: December 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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) Procedure: LVP
Large Volume Paracentesis

  Eligibility

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

Inclusion Criteria:

  1. Patient has cirrhosis of the liver with portal hypertension
  2. Patient has difficult to treat ascites, defined as at least one of the following:

    • Subject requires paracentesis despite treatment with high dose diuretics [at least 80 mg of furosemide (or 2 mg bumetanide) and 200 mg aldactone (or 20 mg amiloride)] within the last 90 days
    • Subject requires repeated paracentesis (cumulative volume of at least 10 L removed) within a 45 day period
    • Subject requires paracentesis and can not tolerate diuretics due to a documented complication of diuretic therapy
  3. Patient has a MELD score ≤18 prior to randomization
  4. Patient is 18 years or older and <70 years old at randomization
  5. Patient has a creatinine ≤ 2.0 mg/dL
  6. Patient has a total bilirubin ≤3.0 mg/dL
  7. Patient has a serum sodium ≥ 130 mmol/L
  8. Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
  9. Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.

Exclusion Criteria:

  1. Patient has more than 6 large volume paracenteses of at least 5 liters each within 90 days prior to randomization
  2. Patient has a history of spontaneous hepatic encephalopathy requiring hospitalization
  3. Patient has hepatic encephalopathy (grade 2 or greater) not responsive to medical management
  4. Patient has known hepatocellular carcinoma
  5. Patient has complete thrombosis of main portal vein
  6. Patient has known pulmonary hypertension (mean PA pressure > 30 mmHg) based on cardiac ultrasound or catheterization
  7. Patient has congestive heart failure
  8. Patient has active bacterial infection
  9. Patient has symptomatic hepatic hydrothorax requiring repetitive thoracenteses
  10. Patient has Type 1 hepatorenal syndrome (HRS)
  11. Patient has Budd-Chiari syndrome
  12. Patient is contraindicated for TIPS placement
  13. Patient has had previous TIPS placement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236339

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States
United States, California
University of California-Los Angeles
Los Angeles, California, United States
Leland Stanford Junior University
Palo Alto, California, United States
United States, Georgia
Piedmont Hospital, Incorporated
Atlanta, Georgia, United States
United States, Illinois
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
United States, Indiana
Indiana University
Indianapolis, Indiana, United States
United States, Kansas
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
United States, Maryland
University of Maryland-Baltimore
Baltimore, Maryland, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, Missouri
University of Washington School of Medicine - Barnes-Jewish Hospital
St Louis, Missouri, United States
United States, New York
Mt. Sinai Medical Center
New York City, New York, United States
United States, North Carolina
Duke University Medical Center
Releigh, North Carolina, United States
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada
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
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 22, 2014