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Studio Clinico Pilota Con Uso di Elettroporazione Irreversibile (IRE) Nel Trattamento di Lesioni Neoplastiche Epatiche Con Localizzazione ad accessibilità Limitata o ad Alto Rischio


N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Liver Cancer, Cholangiocarcinoma, Neoplasm Metastasis

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Trial Information

Studio Clinico Pilota Con Uso di Elettroporazione Irreversibile (IRE) Nel Trattamento di Lesioni Neoplastiche Epatiche Con Localizzazione ad accessibilità Limitata o ad Alto Rischio


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effectiveness of IRE for the treatment of metastatic liver cancer or cholangiocarcinoma.

Outcome Description:

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.

Outcome Time Frame:

1 month post-intervention

Safety Issue:

No

Principal Investigator

Umberto Cillo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Azienda Ospedaliera di Padova

Authority:

Italy: Ethics Committee

Study ID:

2252P

NCT ID:

NCT01442324

Start Date:

February 2011

Completion Date:

Related Keywords:

  • Metastatic Liver Cancer
  • Cholangiocarcinoma
  • Neoplasm Metastasis
  • Laparotomic surgery
  • Laparoscopic surgery
  • Percutaneos tumour ablation
  • Irreversible electroporation (IRE)
  • Neoplasms
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Cholangiocarcinoma

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