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