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
Results First Received: January 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Liver Cirrhosis
Portal Hypertension
Ascites
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TIPS TIPS with GORE® VIATORR® TIPS Endoprosthesis
LVP (Large Volume Paracentesis)

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)


Participant Flow:   Overall Study
    TIPS     LVP (Large Volume Paracentesis)  
STARTED     13     13  
LVP Crossover to TIPS     0     4 [1]
COMPLETED     2     0  
NOT COMPLETED     11     13  
Termination of study by sponsor                 11                 13  
[1] ONLY patients failing LVP and meeting crossover according to protocol definition



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites

Reporting Groups
  Description
TIPS

TIPS with GORE® VIATORR® TIPS Endoprosthesis >

> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis

LVP (Large Volume Paracentesis)

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).

Total Total of all reporting groups

Baseline Measures
    TIPS     LVP (Large Volume Paracentesis)     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: years]
Mean ± Standard Deviation
  58.4  ± 6.6     57.5  ± 8.0     58.0  ± 7.2  
Gender  
[units: participants]
     
Female     6     2     8  
Male     7     11     18  
Region of Enrollment  
[units: participants]
     
United States     11     9     20  
Canada     2     4     6  



  Outcome Measures
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1.  Primary:   Transplant-free Survival   [ Time Frame: Through 24 months ]

2.  Secondary:   Overall Survival   [ Time Frame: Through 24 months ]

3.  Secondary:   Time to Transplant   [ Time Frame: Through 24 months ]

4.  Secondary:   Frequency of Paracentesis   [ Time Frame: Through 24 months ]

5.  Secondary:   Frequency of Hepatic Encephalopathy   [ Time Frame: Through 24 months ]

6.  Secondary:   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) ]

7.  Secondary:   Liver Disease Complications (Adverse Events)   [ Time Frame: Through 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to very low enrollment.No subjects completed 24 month follow-up,sample size too small for adequate statistical analysis.Collected Adverse Events limited to hospitalizations and Liver Disease Complications as defined in protocol.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Arthur Scott / Clinical Study Manager
Organization: W.L. Gore and Associates, Inc.
phone: 623.234.5263
e-mail: artscott@wlgore.com


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