PTFE Covered Stents Versus Naked Stents in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)

April 8, 2015 updated by: University Hospital, Tours

Randomized Study With Medico-economic Evaluation Comparing the Use of PTFE Covered Stents vs Naked Stent in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)

Transjugular intrahepatic portosystemic shunts (TIPS) have been increasingly used for the treatment of complications of portal hypertension in patients with cirrhosis.

The initial experiment of the TIPS was reported during the 1990s with stents of various brands, manufacture and sizes, but all "non covered", thus owing the pseudointimal hyperplasia growing inside the stent, which progressively decreases the diameter of the shunt and thus its efficacy. Since the beginning of the 2000s, appeared stents known as "covered" by polytetrafluoroethylene (PTFE) designed to reduce the obstruction rate and thus the frequency shunt revisions. However, these stents are, on average, 2.5 times more expensive than the non covered stents and the cost-effectiveness ratio of the TIPS according to the type of stents used has not been assessed.

The aim of this multicentric and randomized study is to assess the cost-effectiveness ratio of these 2 principles of TIPS, the one using stents covered by PTFE, relatively expensive but seldom becoming obstructed, and the other using non covered stents, less expensive than PTFE but requiring regular gestures of redilatation.

Population concerned: Patients with a cirrhotic portal hypertension responsible for:

  • recurrent variceal bleeding
  • refractory ascite (or hydrothorax)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33075
        • CHRU Bordeaux
      • Caen, France, 14033
        • Chru Caen
      • Clermont Ferrand, France, 63058
        • CHRU Clermont Ferrand
      • Dijon, France, 21079
        • CHRU DIjon
      • Marseille, France, 13003
        • AP-HM / La Conception
      • Marseille, France, 13385
        • AP-HM / La Timone
      • Nantes, France, 44093
        • CHRU NANTES / Hôtel-Dieu
      • Nantes (st Herblain), France, 44800
        • CHRU NANTES / Hôpital Guillaume et René Laënnec
      • Nice, France, 06202
        • Chru Nice
      • Poitiers, France, 86021
        • CHRU Poitiers
      • Tours, France, 37044
        • CHRU de Tours
      • Villejuif, France, 94804
        • Ap-Hp (Paul Brousse)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of a cirrhosis as documented by previous liverbiopsy or typical clinical signs

  • Indication validated of the TIPS (Bavéno IV), except not-controlled acute hemorrhagic :

    • Recurrent variceal bleeding after failure of the usual pharmacological and endoscopic methods
    • Refractory or recurrent ascites or difficult to treat
    • Refractory Hydrothorax

Exclusion Criteria:

  • Non cirrhotic HTP
  • CHILD C ≥12
  • Complete portal vein thrombosis

  • Usual contra-indication for TIPS :

    • Known or suspected Hepatocarcinoma by increase of the alpha-foetoprotein >100 UI/mL associated with the presence of at least one hepatic nodule
    • Cardiac insufficiency defined by a ventricular fraction of ejection < 40% with the echocardiography preliminary to the procedure
    • Pulmonary arterial hypertension (PAP > 40 mmHg)
    • Hepatic polycystosis
    • Intra-hepatic bile ducts dilatation,
    • Spontaneous clinical recurrent hepatic encephalopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Naked Stents
Device: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)
Vascular Stents
Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)
Transjugular intrahepatic portosystemic shunt (TIPS)
Experimental: B
PTFE Covered Stents
Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)
Transjugular intrahepatic portosystemic shunt (TIPS)
Device: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)
Vascular Stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TIPS permeability rate
Time Frame: one year
one year
Cost of the TIPS and patient care according to the type of stent used brought back to an indicator of effectiveness
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: one year
one year
Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity
Time Frame: one year
one year
Effectiveness criteria : survival rate - recurrence rate of the symptoms having justified the TIPS - various types of dysfunction
Time Frame: one year
one year
Doppler : performance evaluation of Doppler for the diagnosis of dysfunction
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Jean-Marc PERARNAU, Doctor, CHRU Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 15, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STIC07-JMP/TIPS-PTFE
  • 2007-A00857-46 (Other Identifier: EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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