Brief Title
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
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 Type
Interventional
Primary Outcome
Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.
Secondary Outcome
Safety
Condition
Metastatic Liver Cancer
Intervention
Irreversible electroporation (IRE)
Study Arms / Comparison Groups
IRE
Description: Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
5
Start Date
February 2011
Primary Completion Date
September 2012
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Umberto Cillo, MD, +390498218624, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT01442324
Organization ID
2252P
Responsible Party
Principal Investigator
Study Sponsor
Azienda Ospedaliera di Padova
Study Sponsor
Umberto Cillo, MD, Study Chair, Azienda Ospedaliera di Padova
Verification Date
July 2012