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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Cirrhotic Portal Hypertension

Treatments: Device: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore); Procedure: Transjugular intrahepatic portosystemic shunt (TIPS); Device: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)

Study type: Interventional

Funder types: Other

Identifiers

NCT00593528

2007-A00857-46 (Other Identifier)

STIC07-JMP/TIPS-PTFE

Details and patient eligibility

About

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)

Enrollment: 138 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

A

Active Comparator group

Description:

Naked Stents

Treatment:

Device: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis)

Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

B

Experimental group

Description:

PTFE Covered Stents

Treatment:

Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

Device: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore)