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NCT Number: NCT00593528

PTFE Covered Stents Versus Naked Stents 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)

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Key information

Conditions

Cirrhotic Portal Hypertension Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chru Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Vascular Stents

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

Device

Vascular Stents

Transjugular intrahepatic portosystemic shunt (TIPS)

Procedure

Transjugular intrahepatic portosystemic shunt (TIPS)

Primary outcomes

  1. TIPS permeability rate

    Time frame: one year

  2. 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

Secondary outcomes

  1. Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity

    Time frame: one year

  2. Quality of life

    Time frame: one year

  3. Effectiveness criteria : survival rate - recurrence rate of the symptoms having justified the TIPS - various types of dysfunction

    Time frame: one year

  4. Doppler : performance evaluation of Doppler for the diagnosis of dysfunction

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 15, 2008
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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