Clinical Research on Irreversible Electroporation of the Liver

Abstract

As part of a human clinical study regarding the safety of irreversible electroporation (IRE) using the Nanoknife™ for treatment of liver tumors, 75 liver tumor locations were treated in 29 volunteers enrolled in an IRB-approved trial. Adverse events related to the IRE of the liver were cardiac rhythm disturbance in two patients (ventricular tachycardia, atrial fibrillation), pneumothorax (one patient), and brachial plexus neuropraxia related to positioning (two patients). Except for avoidance of direct puncture, no protection was offered to major intrahepatic blood vessels, bile ducts, or adjacent structures such as diaphragm, gall bladder, stomach, or colon. CT and clinical follow-up for 3 months showed no evidence of damage to these structures. The major disadvantage of IRE compared to other ablative modalities is the need for a general anesthetic with muscle relaxants but the low incidence of morbidity related to the ablation outweighed this disadvantage. Cardiac-synchronized delivery of the IRE is necessary to avoid cardiac arrhythmia.