Switching Monopolar No-Touch Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma: A Randomized Clinical Trial

Abstract

<b><i>Introduction:</i></b> A switching monopolar no-touch radiofrequency ablation (RFA) technique is used for small hepatocellular carcinoma (HCC); however, there have not been any randomized clinical trials comparing this technique to the conventional RFA technique. <b><i>Objective:</i></b>This study aims to compare the results of two RFA techniques, and to comparatively identify more effective methods to reduce the progression of local tumors associated with small HCC (≤2.5 cm). <b><i>Methods:</i></b> This prospective randomized clinical trial (NCT03375281) recruited a total of 116 participants (M:F, 93:23; 68.3 ± 8.4 years) between October 2016 and September 2017. The primary outcome was the cumulative incidence of local tumor progression (LTP) after RFA. Secondary outcomes included technical success rate, technique efficacy, and RFA procedure characteristics. Kaplan-Meier analysis and the Cox proportional hazard regression model were used. <b><i>Results:</i></b> The mean follow-up period was 24.1 months. A sufficient ablative margin was more frequently achieved in the no-touch RFA group (57/60 = 95%) than in the conventional RFA group (50/64 = 78.1%) on immediate follow-up CT (<i>p</i> = 0.01). The cumulative incidence of LTP in the no-touch RFA group was significantly lower than that in the conventional RFA group (<i>p</i> = 0.02). In multivariable analysis, no-touch RFA was the only predictive factor for LTP (<i>p</i> = 0.04, hazard ratio = 0.2, 95% confidence interval = 0.04–0.94). <b><i>Conclusions:</i></b> A switching monopolar no-touch RFA technique is a favorable treatment option and provides lower LTP after RFA compared with conventional RFA for small HCC.