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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.
The primary measurement parameter for the purposes of this determination is the evaluation of the response of IRE treated lesions according to modified RECIST criteria using CT images or magnetic resonance imaging performed 20 to 40 days after treatment.
1 month post-intervention
Umberto Cillo, MD
Azienda Ospedaliera di Padova
Italy: Ethics Committee