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使用章鱼电极的切换式单极非接触射频消融术治疗小肝细胞癌:一项随机临床试验

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

作者信息

Park Sae-Jin, Cho Eun Ju, Lee Jeong-Hoon, Yu Su Jong, Kim Yoon Jun, Yoon Jung-Hwan, Kang Hyo-Jin, Yoon Jeong Hee, Lee Dong Ho, Kim Se Hyung, Lee Jae Young, Lee Jeong Min

机构信息

Department of Radiology, Seoul National University Hospital, Seoul, Republic of Korea.

Department of Internal Medicine and Liver Research Institute, College of Medicine, Seoul National University, Seoul, Republic of Korea.

出版信息

Liver Cancer. 2021 Feb;10(1):72-81. doi: 10.1159/000512338. Epub 2020 Dec 8.

Abstract

INTRODUCTION

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.

OBJECTIVE

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).

METHODS

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.

RESULTS

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 ( = 0.01). The cumulative incidence of LTP in the no-touch RFA group was significantly lower than that in the conventional RFA group ( = 0.02). In multivariable analysis, no-touch RFA was the only predictive factor for LTP ( = 0.04, hazard ratio = 0.2, 95% confidence interval = 0.04-0.94).

CONCLUSIONS

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.

摘要

引言

一种切换单极非接触式射频消融(RFA)技术用于治疗小肝细胞癌(HCC);然而,尚无任何随机临床试验将该技术与传统RFA技术进行比较。

目的

本研究旨在比较两种RFA技术的结果,并比较确定更有效的方法以减少与小HCC(≤2.5 cm)相关的局部肿瘤进展。

方法

这项前瞻性随机临床试验(NCT03375281)在2016年10月至2017年9月期间共招募了116名参与者(男:女,93:23;68.3±8.4岁)。主要结局是RFA后局部肿瘤进展(LTP)的累积发生率。次要结局包括技术成功率、技术疗效和RFA手术特征。采用Kaplan-Meier分析和Cox比例风险回归模型。

结果

平均随访期为24.1个月。在即时随访CT上,非接触式RFA组(57/60 = 95%)比传统RFA组(50/64 = 78.1%)更频繁地获得足够的消融边缘(P = 0.01)。非接触式RFA组的LTP累积发生率显著低于传统RFA组(P = 0.02)。在多变量分析中,非接触式RFA是LTP的唯一预测因素(P = 0.04,风险比 = 0.2,95%置信区间 = 0.04-0.94)。

结论

对于小HCC,切换单极非接触式RFA技术是一种有利的治疗选择,与传统RFA相比,RFA后LTP更低。

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