Cirrhotic Portal Hypertension Clinical Trial
Official title:
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)
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01642446 -
Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension
|
N/A |