PTFE Covered Stents Versus Naked Stents in the TIPS (Transjugular Intra-Hepatic Porto-Systemic Shunt) - Full Text View

Sponsored by:	University Hospital, Tours
Information provided by:	University Hospital, Tours
ClinicalTrials.gov Identifier:	NCT00593528

Purpose

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)

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

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official 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)

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:

TIPS permeability rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Quality of life [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Effectiveness criteria : survival rate - recurrence rate of the symptoms having justified the TIPS - various types of dysfunction [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Doppler : performance evaluation of Doppler for the diagnosis of dysfunction [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	130
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
A: Active Comparator Naked Stents	Device: Naked Stents: Wallstent® (Boston Scientific), Luminexx® (Bard), Zilver® (Cook), Palmaz Genesis® and Smart Control® (Cordis) Vascular Stents Procedure: Transjugular intrahepatic portosystemic shunt (TIPS) N/A
B: Experimental PTFE Covered Stents	Device: PTFE Covered Stents: Fluency® (Bard), Advanta V12® (Atrium) and Viatorr® (Gore) Vascular Stents Procedure: Transjugular intrahepatic portosystemic shunt (TIPS) N/A

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593528

Contacts

Contact: Jean-Marc PERARNAU, Doctor	33 2 47 47 59 16	jm.perarnau@chu-tours.fr
Contact: Louis D'ALTEROCHE, Doctor	33 2 47 47 59 65	l.dalteroche@chu-tours.fr

Locations

France
CHRU	Recruiting
TOURS, France, 37000
Contact: Jean-Marc PERARNAU, Doctor 33 2 47 47 59 16 jm.perarnau@chu-tours.fr
Contact: Louis D'ALTEROCHE, Doctor 33 2 47 47 59 65 l.dalteroche@chu-tours.fr
Principal Investigator: Jean-Marc PERARNAU, Doctor
Sub-Investigator: Louis D'ALTEROCHE, Doctor
Sub-Investigator: Jean AYOUB, Doctor
AP-H/ Hôpital La Timone	Recruiting
MARSEILLE, France, 13385
Contact: Vincent VIDAL, Doctor 33 4 91 38 56 75 vincent.vidal@ap-hm.fr
Principal Investigator: Vincent VIDAL, Doctor
Sub-Investigator: Jean-Michel BARTOLI, Professor
Sub-Investigator: Guy MOULIN, Professor
AP-H/ CHU Conception	Recruiting
MARSEILLE, France, 13003
Sub-Investigator: René GEROLAMI, Doctor
Sub-Investigator: Patrick BORENTAIN, Doctor
CHRU	Recruiting
NICE, France, 06202
Contact: Patrick CHEVALLIER, Professor 33 4 92 03 63 53 chevallier.p@chu-nice.fr
Principal Investigator: Patrick CHEVALLIER, Professor
Sub-Investigator: Albert TRAN, Professor
Sub-Investigator: Sébastien NOVELLAS, Doctor
Sub-Investigator: Rodolphe ANTY, Doctor
CHRU	Recruiting
POITIERS, France, 86021
Contact: Carine CHAGNEAU-DERRODE, Doctor 33 5 49 44 43 60 c.chagneau-derrode@chu-poitiers.fr
Principal Investigator: Carine CHAGNEAU-DERRODE, Doctor
Sub-Investigator: Jérome ROUMY, Doctor
CHRU	Recruiting
CAEN, France, 14033
Contact: Thong DAO, Professor 33 2 31 06 45 44 dao-t@chu-caen.fr
Principal Investigator: Thong DAO, Professor
Sub-Investigator: Isabelle OLLIVIER-HOURMAND, Doctor
Sub-Investigator: Vincent LEPENNEC, Doctor
CHRU	Recruiting
CLERMONT FERRAND, France, 63058
Contact: Armand ABERGEL, Professor 33 4 73 75 05 04 aabergel@chu-clermontferrand.fr
Principal Investigator: Armand ABERGEL, Professor
Sub-Investigator: Louis BOYER, Professor
Sub-Investigator: Anca ACHIM, Doctor
Ap-Hp (Paul Brousse)	Recruiting
VILLEJUIF, France, 94804
Contact: Faouzi SALIBA, Professor 33 1 45 59 40 94 faouzi.saliba@pbr.ap-hop-paris.fr
Principal Investigator: Faouzi SALIBA, Professor
Sub-Investigator: Denis CASTAING, Professor
Sub-Investigator: Daniel AZOULAY, Professor
Sub-Investigator: Didier SAMUEL SAMUEL, Professor
CHRU	Recruiting
DIJON, France, 21079
Contact: Jean-Pierre CERCUEIL, Doctor 33 3 80 29 36 86 jean-pierre.cercueil@chu-dijon.fr
Principal Investigator: Jean-Pierre CERCUEIL, Doctor
Sub-Investigator: Denis KRAUSÉ, Professor
Sub-Investigator: Patrick HILLON, Professor
Sub-Investigator: Anne MINELLO, Doctor
Sub-Investigator: Romaric LOFFROY, Doctor
CHRU Hôpital Guillaume et René Laënnec	Recruiting
NANTES (ST HERBLAIN), France, 44800
Contact: Jérôme GOURNAY, Doctor 33 2 40 16 56 83 jerome.gournay@chu-nantes.fr
Principal Investigator: Jérôme GOURNAY, Doctor
Sub-Investigator: Frédéric LERAT, Professor
CHRU Hôpital Hôtel-Dieu	Recruiting
NANTES, France, 44093
Sub-Investigator: Christophe PERRET, Doctor
Sub-Investigator: Claude MASLIAH, Doctor
CHRU	Recruiting
BORDEAUX, France, 33075
Contact: Hervé TRILLAUD, Professor 33 5 56 79 58 00 herve.trillaud@chu-bordeaux.fr
Principal Investigator: Hervé TRILLAUD, Professor
Sub-Investigator: Jean-Frédéric BLANC, Professor
Sub-Investigator: Hervé LAUMONIER, Doctor
Sub-Investigator: Pierre-Henri BERNARD, Doctor

Sponsors and Collaborators

University Hospital, Tours

Investigators

Principal Investigator:

Jean-Marc PERARNAU, Doctor

CHRU TOURS

More Information

Publications:

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.

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

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.

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.

Barrio J, Ripoll C, Bañares R, Echenagusia A, Catalina MV, Camúñez F, Simó 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.

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.

Rössle 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.

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. Epub 2006 Aug 14.

Tripathi D, Redhead D. Transjugular intrahepatic portosystemic stent-shunt: technical factors and new developments. Eur J Gastroenterol Hepatol. 2006 Nov;18(11):1127-33. Review.

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

Responsible Party:	University Hospital of TOURS ( Dr Jean-Marc PERARNAU )
Study ID Numbers:	STIC07-JMP/TIPS-PTFE, 2007-A00857-46
Study First Received:	December 17, 2007
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00593528
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Tours:

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

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Vascular Diseases
Hypertension, Portal

Liver Cirrhosis
Portal hypertension
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009