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

NCT00593528 | Completed

• 2 other identifiers: STIC07-JMP/TIPS-PTFE2007-A00857-46
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 12

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)

Conditions

Cirrhotic Portal Hypertension

Keywords

Cirrhosis, STIC TIPS, Portal Hypertension, Transjugular Intrahepatic Portosystemic Shunt , Stents, PTFE; cirrhotic HTP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

A

ACTIVE COMPARATOR

Naked Stents

Device: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis); Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

B

EXPERIMENTAL

PTFE Covered Stents

Device: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore); Procedure: Transjugular intrahepatic portosystemic shunt (TIPS)

Interventions

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

Vascular Stents

B

Transjugular intrahepatic portosystemic shunt (TIPS) PROCEDURE

Transjugular intrahepatic portosystemic shunt (TIPS)

A; B

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

Vascular Stents

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (12)

Chru Bordeaux

Bordeaux, 33075, France

Location

Chru Caen

Caen, 14033, France

Location

Chru Clermont Ferrand

Clermont-Ferrand, 63058, France

Location

Chru Dijon

Dijon, 21079, France

Location

AP-HM / La Conception

Marseille, 13003, France

Location

AP-HM / La Timone

Marseille, 13385, France

Location

CHRU NANTES / Hôtel-Dieu

Nantes, 44093, France

Location

CHRU NANTES / Hôpital Guillaume et René Laënnec

Nantes, 44800, France

Location

Chru Nice

Nice, 06202, France

Location

Chru Poitiers

Poitiers, 86021, France

Location

CHRU de TOURS

Tours, 37044, France

Location

Ap-Hp (Paul Brousse)

Villejuif, 94804, France

Location

Related Publications (12)

• Perarnau JM, Noeldge G, Rossle M. [Intrahepatic portacaval anastomosis by the transjugular approach. Use of the Palmaz endoprosthesis]. Presse Med. 1991 Nov 9;20(36):1770-2. French.

  PMID: 1836597 BACKGROUND

• Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Peron JM, Abraldes JG, Bouchard L, Bilbao JI, Bosch J, Rousseau H, Vinel JP. Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study. Gastroenterology. 2004 Feb;126(2):469-75. doi: 10.1053/j.gastro.2003.11.016.

  PMID: 14762784 BACKGROUND

• Nishimine K, Saxon RR, Kichikawa K, Mendel-Hartvig J, Timmermans HA, Shim HJ, Uchida BT, Barton RE, Keller FS, Rosch J. Improved transjugular intrahepatic portosystemic shunt patency with PTFE-covered stent-grafts: experimental results in swine. Radiology. 1995 Aug;196(2):341-7. doi: 10.1148/radiology.196.2.7617843.

  PMID: 7617843 BACKGROUND

• Angermayr B, Cejna M, Koenig F, Karnel F, Hackl F, Gangl A, Peck-Radosavljevic M; Vienna TIPS Study Group. Survival in patients undergoing transjugular intrahepatic portosystemic shunt: ePTFE-covered stentgrafts versus bare stents. Hepatology. 2003 Oct;38(4):1043-50. doi: 10.1053/jhep.2003.50423.

  PMID: 14512892 BACKGROUND

• Charon JP, Alaeddin FH, Pimpalwar SA, Fay DM, Olliff SP, Jackson RW, Edwards RD, Robertson IR, Rose JD, Moss JG. Results of a retrospective multicenter trial of the Viatorr expanded polytetrafluoroethylene-covered stent-graft for transjugular intrahepatic portosystemic shunt creation. J Vasc Interv Radiol. 2004 Nov;15(11):1219-30. doi: 10.1097/01.RVI.0000137434.19522.E5.

  PMID: 15525740 BACKGROUND

• Barrio J, Ripoll C, Banares R, Echenagusia A, Catalina MV, Camunez F, Simo G, Santos L. Comparison of transjugular intrahepatic portosystemic shunt dysfunction in PTFE-covered stent-grafts versus bare stents. Eur J Radiol. 2005 Jul;55(1):120-4. doi: 10.1016/j.ejrad.2004.10.007.

  PMID: 15950109 BACKGROUND

• Vignali C, Bargellini I, Grosso M, Passalacqua G, Maglione F, Pedrazzini F, Filauri P, Niola R, Cioni R, Petruzzi P. TIPS with expanded polytetrafluoroethylene-covered stent: results of an Italian multicenter study. AJR Am J Roentgenol. 2005 Aug;185(2):472-80. doi: 10.2214/ajr.185.2.01850472.

  PMID: 16037523 BACKGROUND

• Rossle M, Siegerstetter V, Euringer W, Olschewski M, Kromeier J, Kurz K, Langer M. The use of a polytetrafluoroethylene-covered stent graft for transjugular intrahepatic portosystemic shunt (TIPS): Long-term follow-up of 100 patients. Acta Radiol. 2006 Sep;47(7):660-6. doi: 10.1080/02841850600806324.

  PMID: 16950701 BACKGROUND

• Gandini R, Konda D, Simonetti G. Transjugular intrahepatic portosystemic shunt patency and clinical outcome in patients with Budd-Chiari syndrome: covered versus uncovered stents. Radiology. 2006 Oct;241(1):298-305. doi: 10.1148/radiol.2411050347. Epub 2006 Aug 14.

  PMID: 16908675 BACKGROUND

• Tripathi D, Redhead D. Transjugular intrahepatic portosystemic stent-shunt: technical factors and new developments. Eur J Gastroenterol Hepatol. 2006 Nov;18(11):1127-33. doi: 10.1097/01.meg.0000236871.78280.a7.

  PMID: 17033430 BACKGROUND

• Riggio O, Angeloni S, Nicolao F, Ridola L, Salvatori FM et al. Hepatic Encephalopathy is more frequent and severe after Transjugular intrahepatic portosystemeic Shunt (TIPS) with PTFE-coveted stent-grafts. Hepatology 2006;44, suppl 1, 232

  BACKGROUND

• Perarnau JM, Le Gouge A, Nicolas C, d'Alteroche L, Borentain P, Saliba F, Minello A, Anty R, Chagneau-Derrode C, Bernard PH, Abergel A, Ollivier-Hourmand I, Gournay J, Ayoub J, Gaborit C, Rusch E, Giraudeau B; STIC-TIPS group. Covered vs. uncovered stents for transjugular intrahepatic portosystemic shunt: a randomized controlled trial. J Hepatol. 2014 May;60(5):962-8. doi: 10.1016/j.jhep.2014.01.015. Epub 2014 Jan 27.

  PMID: 24480619 RESULT

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Study Officials

• Jean-Marc PERARNAU, Doctor

  CHRU TOURS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: January 15, 2008
• Study Start: February 18, 2008
• Primary Completion: July 11, 2011
• Study Completion: July 11, 2011
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (12)