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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Vascular Stents
Vascular Stents
Transjugular intrahepatic portosystemic shunt (TIPS)
Chru Bordeaux
Bordeaux, France
Chru Caen
Caen, France
Chru Clermont Ferrand
Clermont-Ferrand, France
Chru Dijon
Dijon, France
AP-HM / La Conception
Marseille, France
AP-HM / La Timone
Marseille, France
CHRU NANTES / Hôtel-Dieu
Nantes, France
CHRU NANTES / Hôpital Guillaume et René Laënnec
Nantes, France
Chru Nice
Nice, France
Chru Poitiers
Poitiers, France
...and 2 more locations
TIPS permeability rate
Time frame: 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
Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity
Time frame: one year
Quality of life
Time frame: one year
Effectiveness criteria : survival rate - recurrence rate of the symptoms having justified the TIPS - various types of dysfunction
Time frame: one year
Doppler : performance evaluation of Doppler for the diagnosis of dysfunction
Time frame: one year
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