Status:
UNKNOWN
Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma
Lead Sponsor:
Azienda Ospedaliera di Padova
Conditions:
Metastatic Liver Cancer
Cholangiocarcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 pilo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01442324
Start Date
February 1 2011
Last Update
July 18 2012
Active Locations (1)
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1
Azienda Ospedaliera di Padova
Padua, PD, Italy, I-35128