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

Not Applicable

Completed

• Conditions: Cirrhotic Portal Hypertension

• Registration Number: NCT00593528
• Lead Sponsor: University Hospital, Tours

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Study Start: 2008-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity	one year
Quality of life	one year

Trial Locations

Locations (12)

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 / Hôpital Guillaume et René Laënnec; 🇫🇷 Nantes (st Herblain), France

CHRU NANTES / Hôtel-Dieu; 🇫🇷 Nantes, France

Chru Nice; 🇫🇷 Nice, France

Chru Poitiers; 🇫🇷 Poitiers, France

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