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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Azienda Ospedaliera di Padova.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Prof. Umberto Cillo, Azienda Ospedaliera di Padova Identifier:
First received: September 27, 2011
Last updated: July 17, 2012
Last verified: July 2012
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.

Condition Intervention
Metastatic Liver Cancer
Neoplasm Metastasis
Procedure: Irreversible electroporation (IRE)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Studio Clinico Pilota Con Uso di Elettroporazione Irreversibile (IRE) Nel Trattamento di Lesioni Neoplastiche Epatiche Con Localizzazione ad accessibilità Limitata o ad Alto Rischio

Resource links provided by NLM:

Further study details as provided by Azienda Ospedaliera di Padova:

Primary Outcome Measures:
  • Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma. [ Time Frame: 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:
  • Safety [ Time Frame: 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 [ Time Frame: 2 years post-intervention ]

Estimated Enrollment: 5
Study Start Date: February 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IRE
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)
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.
Other Names:
  • NanoKnife™ System
  • AngioDynamics

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01442324

Azienda Ospedaliera di Padova
Padova, PD, Italy, I-35128
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Study Chair: Umberto Cillo, MD Azienda Ospedaliera di Padova
Principal Investigator: Alessandro Vitale, MD Azienda Ospedaliera di Padova
  More Information

Additional Information:
Responsible Party: Prof. Umberto Cillo, Director of the Hepatobiliary Surgery and Liver Transplantation Unit, Azienda Ospedaliera di Padova Identifier: NCT01442324     History of Changes
Other Study ID Numbers: 2252P 
Study First Received: September 27, 2011
Last Updated: July 17, 2012

Keywords provided by Azienda Ospedaliera di Padova:
Laparotomic surgery
Laparoscopic surgery
Percutaneos tumour ablation
Irreversible electroporation (IRE)

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes processed this record on February 17, 2017