Clinical effectiveness of bipolar radiofrequency ablation for small liver cancers

Abstract

Radiofrequency ablation (RFA) is minimally invasive and can achieve a high rate of cure of liver cancer. This study was conducted to evaluate the efficacy and safety of a bipolar RFA device (CelonPOWER System) in the treatment of Japanese liver cancer patients. The study was a multicenter, single-group, open-label trial. The indications for RFA were based on the Japanese guidelines for the management of liver cancer. The subjects had a Child-Pugh classification of A or B, and the target tumors were defined as nodular, numbering up to 3 lesions, each of which was 3cm or less in diameter, or solitary lesions up to 4cm in diameter. To test for the non-inferiority of the CelonPOWER System, this system was compared with the Cool-tip RF System, which has already been approved in Japan, in terms of the complete necrosis rate (CNR). The CNR obtained with the CelonPOWER System was 97.8% (88/90 patients). The CNR obtained with the Cool-tip RF System was 86.2% (50/58 patients), confirming the non-inferiority of the CelonPOWER System (p<0.001, Fisher's exact test based on binomial distribution). Throughout the treatment and follow-up periods, there were no adverse events regarding safety that were uniquely related to the CelonPOWER System and there were no cases of device failure. The CelonPOWER System was confirmed to be an effective and safe RFA device. It could become extensively used as a safe next-generation RFA device, reducing the physical burden on patients.