Early TIPS for Ascites Study

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01236339
• Other study ID #: VTR 10-03
• Status: Terminated
• Phase: N/A
• First received: November 4, 2010
• Last updated: May 1, 2014
• Start date: December 2010
• Est. completion date: March 2013

Study information

• Verified date: May 2014
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ascites
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland-Baltimore	Baltimore	Maryland
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Frequency of Paracentesis	Number of paracentesis post randomization	Through 24 months	No
Secondary	Frequency of Hepatic Encephalopathy	Number of episodes of West Haven grade 2 or greater	Through 24 months	No
Secondary	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)	No
Secondary	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	No