Clinical trial NCT01442324: Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Liver Cancer
Cholangiocarcinoma
Neoplasm Metastasis
Keywords: Laparotomic surgery
Laparoscopic surgery
Percutaneos tumour ablation
Irreversible electroporation (IRE)
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.
timeFrame: 1 month post-intervention
Secondary outcomes:
measure: Safety
timeFrame: 30 days post-intervention
measure: Time to in situ recurrence
timeFrame: 2 years post-intervention
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: PD
Study officials:
affiliation: Azienda Ospedaliera di Padova
name: Umberto Cillo, MD
role: STUDY_CHAIR
affiliation: Azienda Ospedaliera di Padova
name: Alessandro Vitale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.