Cirrhotic Portal Hypertension
Conditions
Keywords
Cirrhosis, STIC TIPS, Portal Hypertension, Transjugular Intrahepatic Portosystemic Shunt , Stents, PTFE, cirrhotic HTP
Brief summary
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)
Interventions
DEVICENaked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)
Vascular Stents
DEVICEPTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)
Vascular Stents
Transjugular intrahepatic portosystemic shunt (TIPS)
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Outcome results
None listed