Background

Recently introduced no-touch radiofrequency ablation (RFA) of hepatocellular carcinoma (HCC) has the potential to improve local tumor control.

Purpose

To evaluate midterm clinical outcomes of monopolar no-touch RFA in single HCCs 2.5 cm or smaller.

Materials and Methods

In this multicenter clinical trial (ClinicalTrials.gov: NCT03375281), participants were evaluated for eligibility from November 2017 to January 2019. Patients with single HCCs 2.5 cm or smaller planning to be treated with no-touch RFA were enrolled. The rate of successful no-touch RFA, defined as performing RFA without violation of the tumor itself, was recorded. Multivariable logistic regression analysis was used to determine associated factors for failure of no-touch RFA. Development of major complication after no-touch RFA was also recorded. Cumulative incidence of local tumor progression (LTP) and recurrence-free survival were estimated by using the Kaplan-Meier method.

Results

A total of 140 participants (mean age, 62 years ± 9 [standard deviation]; 106 men) were evaluated. No-touch RFA was successfully performed in 128 participants (128 of 140; 91.4%), and conversion to tumor puncture RFA was undertaken in 12 participants because of the lack of a safe access route. By using either no-touch RFA or conversion to tumor puncture RFA, all participants achieved technical success of RFA, which was defined as complete coverage of target tumor by ablation zone. Insufficient peritumoral parenchyma (<5 mm width around more than half portion of tumor; odds ratio, 74; 95% CI: 18, 309; P < .001) was the only significant predictive factor for failure of the no-touch technique. Among the 140 participants, LTP developed in two participants, and the estimated 1- and 2-year cumulative incidence of LTP was 0.7% and 1.6%, respectively. The estimated 1- and 2-year recurrence-free survival was 82.8% and 74.1%, respectively.

Conclusion

No-touch radiofrequency ablation was an effective and safe treatment method for small hepatocellular carcinomas (≤2.5 cm), with 1.6% of cumulative incidence of local tumor progression at 2 years.

© RSNA, 2021

Online supplemental material is available for this article.

See also the editorial by Soulen and García-Mónaco in this issue.

中文翻译：

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非接触式射频消融治疗小肝癌的结果：一项多中心临床试验

背景

最近引入的肝细胞癌 (HCC) 的非接触式射频消融 (RFA) 具有改善局部肿瘤控制的潜力。

目的

评估单极非接触式 RFA 在 2.5 cm 或更小的单个 HCC 中的中期临床结果。

材料和方法

在这项多中心临床试验 ( ClinicalTrials.gov：NCT03375281 ) 中，参与者在 2017 年 11 月至 2019 年 1 月期间接受了资格评估。招募了计划接受非接触式 RFA 治疗的 2.5 厘米或更小的单发 HCC 患者。记录了成功的非接触式 RFA 率，定义为在不侵犯肿瘤本身的情况下执行 RFA。多变量逻辑回归分析用于确定非接触式 RFA 失败的相关因素。还记录了非接触式 RFA 后主要并发症的发展。使用 Kaplan-Meier 方法估计局部肿瘤进展 (LTP) 的累积发生率和无复发生存率。

结果

共评估了 140 名参与者（平均年龄，62 岁 ± 9 [标准差]；106 名男性）。128 名参与者（140 名中的 128 名；91.4%）成功进行了非接触式 RFA，由于缺乏安全的通路，12 名参与者转为肿瘤穿刺 RFA。通过使用非接触式 RFA 或转换为肿瘤穿刺 RFA，所有参与者都取得了 RFA 的技术成功，其定义为消融区完全覆盖目标肿瘤。瘤周实质不足（肿瘤一半以上宽度<5 mm；优势比，74；95% CI：18, 309；P< .001) 是无触摸技术失败的唯一重要预测因素。在 140 名参与者中，两名参与者出现 LTP，估计 LTP 的 1 年和 2 年累积发生率分别为 0.7% 和 1.6%。估计的 1 年和 2 年无复发生存率分别为 82.8% 和 74.1%。

结论

无接触射频消融是治疗小肝癌（≤2.5 cm）的一种安全有效的治疗方法，2年局部肿瘤进展的累积发生率为1.6%。

© 北美放射学会，2021

本文提供在线补充材料。

另见 Soulen 和 García-Mónaco 在本期的社论。