The Safety and Efficacy of Irreversible Electroporation for the Treatment of Perivascular Liver Cancers

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

October 1, 2023

Study Completion Date

December 31, 2026

Conditions
Liver CancerAblation TechniquesRadiology
Interventions
DEVICE

Irreversible Electroporation Ablation Generator

The irreversible electroporation ablation system (Irreversible Electroporation Ablation Generator) used in this study delivers an ablation field with a voltage of 3,000 volts. It received U.S. Food and Drug Administration (FDA) approval in 2023 but has not yet been introduced in Taiwan. This study will target participants with malignant liver tumors who are unsuitable for surgical resection but are eligible for local ablation therapy, specifically those with tumors located adjacent to the inferior vena cava, hepatic veins, or within 1 cm of the main trunks of both portal veins. A total of 20 participants will undergo ablation treatment under intubation and general anesthesia. Postoperative monitoring will focus on potential complications, and participants will be followed for four months to assess complete tumor ablation and intrahepatic recurrence, in order to verify the clinical feasibility and advantages of this system.

Trial Locations (1)

100

National Taiwan University Hospital, Taipei

All Listed Sponsors
lead

National Taiwan University Hospital

OTHER

NCT07214363 - The Safety and Efficacy of Irreversible Electroporation for the Treatment of Perivascular Liver Cancers | Biotech Hunter | Biotech Hunter