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

Not Applicable

• Conditions: Metastatic Liver Cancer; Cholangiocarcinoma; Neoplasm Metastasis
• Interventions: Procedure: Irreversible electroporation (IRE)

• Registration Number: NCT01442324
• Lead Sponsor: Azienda Ospedaliera di Padova

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18
• Primary Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IRE	Irreversible electroporation (IRE)	Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

Primary Outcome Measures

Name	Time	Method
Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.	1 month post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Safety	30 days post-intervention	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.
Time to in situ recurrence	2 years post-intervention

Trial Locations

Locations (1)

Azienda Ospedaliera di Padova; 🇮🇹 Padova, PD, Italy