Pilot Study on the Evaluation of Irreversible Electroporation Technique in Infiltrating Perihilar Cholangiocarcinoma

• 18-75 years old
• Patient with infiltrating cholangiocarcinoma of the gallstone convergence considered as unresectable on the pre-operative imaging data performed during the month preceding inclusion, and in multidisciplinary consultation meeting specialised in digestive oncology
• Histologically (or cytologically) proven tumor of less than 4 cm of the largest diameter
• World Health Organization Performance Index 0 or 1
• No history of other cancer, except baso-cellular skin carcinoma or epidermoid cervix cancer or any other cancer in complete remission for more than 3 years
• No prior radiotherapy for cholangiocarcinoma
• Biological analyses performed during the month preceding inclusion : hepatic enzymes (AST and ALT \<3N), preserved renal function (creatinine clearance according to Modification of the Diet in Renal Disease >50ml/min); bilirubin \<3N; bile drainage must be correct with a bilirubin below 3N , with or without drainage/prothesis, hemoglobin >9g/dL, leucocytes >3500/mm3, platelets >75000/mm3, prothrombin rate >70%
• Signature of the informed consent

Exclusion Criteria:

• Cholangiocarcinoma of more than 4cm diameter or resectable according tio the imaging data
• Severe and/or uncontrolled (cardiac, pulmonary, renal, liver decompensation...) visceral failure, in the 6 months preceding the study
• Visceral metastases or peritoneal carcinosis
• History of cancers except if remission for more than 3 years, in-situ cancer, epidermoid or baso-cellular cancer
• Metal biliary prothesis non extractable
• Patient with history of epileptic events
• History of myocard infarction for less than 6 months
• Unstabilised coronary disease for at least 6 months
• Cardiac rhythm trouble or QT space above 550ms without treatment
• Patient eligible to liver transplant
• Patient naive of chemiotherapy
• Patient with a pacemaker, an implanted automatic defibrillator or an automatic electronic device or an electronic device with metal pieces
• Patient with contra-indication to the use of NanoKnife system
• History of hypersensitivity to gadolinium or to iodized contrast product not allowing a suitable radiologic monitoring
• Refusal or language or psychic incapacity to sign the informed consent
• Subject who cannot submit to the constraints of the protocol (subjects for which an MRI or a scan is contra-indicated, claustrophobic subjects, non cooperative or not able to come to the follow-up visits)
• Concomitant participation to another study
• Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
• Women at age to procreate and not using effective contraception