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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cholangiocarcinoma, Metastatic Liver Cancer, Neoplasm Metastasis

Intervention / Treatment
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* Procedure: Irreversible electroporation (IRE)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRE<br>Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation. | Procedure: Irreversible electroporation (IRE)<br>* Needle-like electrodes are inserted through the liver and in the lesion without exceeding its deepest margin, at which point the IRE NanoKnife™ System (AngioDynamics) is started.<br>* Other names: AngioDynamics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The safety endpoint will be the occurrence of serious adverse events related to treatment within 30 days of treatment. All adverse events will be classified according to CTCAE version 3.0 criteria. | 30 days post-intervention | 
| Time to in situ recurrence |  | 2 years post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparotomic surgery, Laparoscopic surgery, Percutaneos tumour ablation, Irreversible electroporation (IRE)