Clinical trial NCT00593528: PTFE Covered Stents Versus Naked Stents in the TIPS (Transjugular Intra-hepatic Porto-systemic Shunt)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhotic Portal Hypertension
Keywords: Cirrhosis, STIC TIPS, Portal Hypertension, Transjugular Intrahepatic Portosystemic Shunt , Stents, PTFE
cirrhotic HTP
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility 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

Primary outcomes:
measure: TIPS permeability rate
timeFrame: one year
measure: Cost of the TIPS and patient care according to the type of stent used brought back to an indicator of effectiveness
timeFrame: one year
Secondary outcomes:
measure: Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity
timeFrame: one year
measure: Quality of life
timeFrame: one year
measure: Effectiveness criteria : survival rate - recurrence rate of the symptoms having justified the TIPS - various types of dysfunction
timeFrame: one year
measure: Doppler : performance evaluation of Doppler for the diagnosis of dysfunction
timeFrame: one year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chru Bordeaux
city: Caen
country: France
facility: Chru Caen
city: Clermont Ferrand
country: France
facility: Chru Clermont Ferrand
city: Dijon
country: France
facility: Chru Dijon
city: Marseille
country: France
facility: AP-HM / La Conception
city: Marseille
country: France
facility: AP-HM / La Timone
city: Nantes (st Herblain)
country: France
facility: CHRU NANTES / Hôpital Guillaume et René Laënnec
city: Nantes
country: France
facility: CHRU NANTES / Hôtel-Dieu
city: Nice
country: France
facility: Chru Nice
city: Poitiers
country: France
facility: Chru Poitiers
city: Tours
country: France
facility: CHRU de TOURS
city: Villejuif
country: France
facility: Ap-Hp (Paul Brousse)
Study officials:
affiliation: CHRU TOURS
name: Jean-Marc PERARNAU, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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