Major RF Ablations of Hepatomas Under MR Thermometry Monitoring

Object of the study: To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of reduction of the number of procedure required to obtain complete ablation of the tumors. Experimental plan : This pilot study consist to perform in a single center a single procedure of the multipolar RF ablation under MR temperature monitoring for the treatment of up to three HCC with diameter ranging from 5 cm and 10 cm in 20 inoperable patients. The main judgement criterion of the study will be the rate of complete ablation one month after one RFA procedure performed under MR temperature monitoring. The secondary criteria are, the 2-years local recurrence rate (after the first initial RF ablation procedure performed under MR temperature imaging ± additional RF ablation procedures under ultrasound monitoring in case of remnant viable foci of tumor), the potential reduction of the number of RF procedures required to achieve complete necrosis and the complication rate of RF ablation procedure performed under MR temperature monitoring. In exploratory attempt, the study will include comparative assessment of these criteria with a historic leg of patients previously treated by the same operator in the same center for similar large tumor by multipolar RFA but using exclusively ultrasound monitoring.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Patient of 18 year old.
* Up to 3 tumors unresectable suspected to be HCC according the criteria as previously defined by EASL and recently revised by AASLD among them at least one having a maximal diameter equal or larger than 5 cm.
* Proof of underlying cirrhosis.
* Multidisciplinary decision of RF ablation treatment
* Informed consent of patient
* Available healthcare insurance

Exclusion Criteria:

* Patient with short term life training uncontrollable disease
* Pregnancy
* Follow up Impossible
* Contra indication for general anesthesia
* Contra indication for MR examination with gadolinium injection
* Tumor located at less than 10 mm from colonic wall or main biliary tract
* Tumor invisible on MR examination
* Absence of safe percutaneous course to puncture the tumor
* Child - Pugh B or C cirrhosis
* Abundant ascites
* PROTHROMBIN activity \< 50 %
* Platelet count \< 40 .10 3/ml
* Antecedent of ascitis decompensation
* Severe portal hypertension defined by the presence of large oesophageal variceal (grade 2) , of radiological ascitis or umbilical vein repermeabilisation
* Elevation of transaminases (\>3 upper limit normal range)
* Antecedent of biliodigestive anastomosis
* Antecedent of endoscopic sphincterotomy

• BACKGROUNDN'Kontchou G, Mahamoudi A, Aout M, Ganne-Carrie N, Grando V, Coderc E, Vicaut E, Trinchet JC, Sellier N, Beaugrand M, Seror O. Radiofrequency ablation of hepatocellular carcinoma: long-term results and prognostic factors in 235 Western patients with cirrhosis. Hepatology. 2009 Nov;50(5):1475-83. doi: 10.1002/hep.23181. PMID 19731239
• BACKGROUNDSeror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15. PMID 18483229
• BACKGROUNDSeror O, Lepetit-Coiffe M, Quesson B, Trillaud H, Moonen CT. Quantitative magnetic resonance temperature mapping for real-time monitoring of radiofrequency ablation of the liver: an ex vivo study. Eur Radiol. 2006 Oct;16(10):2265-74. doi: 10.1007/s00330-006-0210-9. Epub 2006 Apr 11. PMID 16607496
• BACKGROUNDSeror O, Lepetit-Coiffe M, Le Bail B, de Senneville BD, Trillaud H, Moonen C, Quesson B. Real time monitoring of radiofrequency ablation based on MR thermometry and thermal dose in the pig liver in vivo. Eur Radiol. 2008 Feb;18(2):408-16. doi: 10.1007/s00330-007-0761-4. Epub 2007 Sep 26. PMID 17899103
• BACKGROUNDLepetit-Coiffe M, Laumonier H, Seror O, Quesson B, Sesay MB, Moonen CT, Grenier N, Trillaud H. Real-time monitoring of radiofrequency ablation of liver tumors using thermal-dose calculation by MR temperature imaging: initial results in nine patients, including follow-up. Eur Radiol. 2010 Jan;20(1):193-201. doi: 10.1007/s00330-009-1532-1. Epub 2009 Aug 6. PMID 19657650