Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma
NCT ID: NCT01442324
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
5 participants
INTERVENTIONAL
2011-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IRE
Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera di Padova
OTHER
Responsible Party
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Prof. Umberto Cillo
Director of the Hepatobiliary Surgery and Liver Transplantation Unit
Principal Investigators
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Umberto Cillo, MD
Role: STUDY_CHAIR
Azienda Ospedaliera di Padova
Alessandro Vitale, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera di Padova
Locations
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Azienda Ospedaliera di Padova
Padua, PD, Italy
Countries
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Central Contacts
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Facility Contacts
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Umberto Cillo, MD
Role: primary
Alessandro Vitale, MD
Role: backup
References
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Ball C, Thomson KR, Kavnoudias H. Irreversible electroporation: a new challenge in "out of operating theater" anesthesia. Anesth Analg. 2010 May 1;110(5):1305-9. doi: 10.1213/ANE.0b013e3181d27b30. Epub 2010 Feb 8.
Onik G, Mikus P, Rubinsky B. Irreversible electroporation: implications for prostate ablation. Technol Cancer Res Treat. 2007 Aug;6(4):295-300. doi: 10.1177/153303460700600405.
Esser AT, Smith KC, Gowrishankar TR, Weaver JC. Towards solid tumor treatment by irreversible electroporation: intrinsic redistribution of fields and currents in tissue. Technol Cancer Res Treat. 2007 Aug;6(4):261-74. doi: 10.1177/153303460700600402.
Al-Sakere B, Andre F, Bernat C, Connault E, Opolon P, Davalos RV, Rubinsky B, Mir LM. Tumor ablation with irreversible electroporation. PLoS One. 2007 Nov 7;2(11):e1135. doi: 10.1371/journal.pone.0001135.
Related Links
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Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)
Other Identifiers
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2252P
Identifier Type: -
Identifier Source: org_study_id