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

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Cirrhotic Portal Hypertension

Intervention / Treatment
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* Device: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)
* Device: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)
* Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cirrhosis, STIC TIPS, Portal Hypertension, Transjugular Intrahepatic Portosystemic Shunt , Stents, PTFE, cirrhotic HTP