Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma

Studio Clinico Pilota Con Uso di Elettroporazione Irreversibile (IRE) Nel Trattamento di Lesioni Neoplastiche Epatiche Con Localizzazione ad accessibilità Limitata o ad Alto Rischio

Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to metastatic liver cancer and cholangiocarcinoma, where the current therapeutic arsenal is inadequate or counter-indicated.

To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.

Inclusion Criteria:

• older than 18 years,
• male or female,
• diagnosis of secondary liver cancer or cholangiocarcinoma based on positive biopsy or noninvasive criteria,
• presence of at least one lesion untreatable by surgical resection or ablation for microwave or radio frequency,
• the target nodule must have a diameter of ≤ 5 cm
• ECOG score(Eastern Cooperative Oncology Group) 0,
• ASA score (American Society of Anesthesiologists) ≤ 3,
• prothrombin time ratio >50%
• platelet count >50x10^9/l,
• patient's ability to discontinue anticoagulant and antiplatelet therapy for seven days before and seven days after surgery with NanoKnife™,
• ability to understand and willingness to sign the written informed consent form (ICF),
• life expectancy of at least 3 months.

Exclusion Criteria:

• presence of more than 5 liver lesions,
• previous treatment of the target nodule,
• patient received systemic chemotherapy within 30 days of treatment with the IRE NanoKnife™,
• heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker),
• pregnant women or women of childbearing potential not using an acceptable method of contraception,
• patient undergoing treatment with an investigational drug within 30 days of treatment with the IRE NanoKnife™,
• in the opinion of the researcher, anyone who can not follow the calendar of visits and assessments of the Protocol.