NCT01442324

Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Azienda Ospedaliera di Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Liver Cancer
• Cholangiocarcinoma
• Neoplasm Metastasis

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-09-01
• First posted: 2011-09-28
• Last updated: 2012-07-18

Locations

1 site across 1 country: Italy