Cirrhotic Portal Hypertension Clinical Trial
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)
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)
| Status | Completed |
| Enrollment | 138 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Chru Bordeaux | Bordeaux | |
| France | Chru Caen | Caen | |
| France | Chru Clermont Ferrand | Clermont Ferrand | |
| France | Chru Dijon | Dijon | |
| France | AP-HM / La Conception | Marseille | |
| France | AP-HM / La Timone | Marseille | |
| France | CHRU NANTES / Hôtel-Dieu | Nantes | |
| France | CHRU NANTES / Hôpital Guillaume et René Laënnec | Nantes (st Herblain) | |
| France | Chru Nice | Nice | |
| France | Chru Poitiers | Poitiers | |
| France | CHRU de TOURS | Tours | |
| France | Ap-Hp (Paul Brousse) | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Tours |
France,
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. — View Citation
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. — View Citation
Bureau C, Garcia-Pagan JC, Otal P, Pomier-Layrargues G, Chabbert V, Cortez C, Perreault P, Péron 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. — View 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. — View 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. Epub 2006 Aug 14. — View Citation
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. — View Citation
Perarnau JM, Noeldge G, Rössle M. [Intrahepatic portacaval anastomosis by the transjugular approach. Use of the Palmaz endoprosthesis]. Presse Med. 1991 Nov 9;20(36):1770-2. French. — View 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
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. — View 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. Review. — View 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | TIPS permeability rate | one year | Yes | |
| Primary | Cost of the TIPS and patient care according to the type of stent used brought back to an indicator of effectiveness | one year | Yes | |
| Secondary | Tolerance criteria : frequency of early complications like early thrombosis - probability of hepatic encephalopathy occurrence and gravity | one year | Yes | |
| Secondary | Quality of life | one year | Yes | |
| Secondary | Effectiveness criteria : survival rate - recurrence rate of the symptoms having justified the TIPS - various types of dysfunction | one year | Yes | |
| Secondary | Doppler : performance evaluation of Doppler for the diagnosis of dysfunction | one year | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01642446 -
Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension
|
N/A |