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无接触射频消融治疗小肝癌的疗效:多中心临床试验。

Outcome of No-Touch Radiofrequency Ablation for Small Hepatocellular Carcinoma: A Multicenter Clinical Trial.

机构信息

From the Department of Radiology, Seoul National University Hospital, Seoul, Korea (D.H.L., J.M.L.); Department of Radiology, Samsung Medical Center, -Sungkyunkwan University School of Medicine, Seoul, Korea (M.W.L.); Department of Radiology, Seoul National University College of Medicine, Seoul, Korea (J.M.L.); Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea (P.N.K.); Department of Radiology, Eunpyeong St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea (J.Y.L.); and Department of Radiology, Konkuk University College of Medicine, Seoul, Korea (H.S.P.).

出版信息

Radiology. 2021 Oct;301(1):229-236. doi: 10.1148/radiol.2021210309. Epub 2021 Jul 27.

DOI:10.1148/radiol.2021210309
PMID:34313474
Abstract

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 (: 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; < .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 See also the editorial by Soulen and García-Mónaco in this issue.

摘要

背景

最近引入的肝细胞癌(HCC)无接触射频消融(RFA)有可能提高局部肿瘤控制率。目的:评估单极无接触 RFA 治疗单个 2.5cm 或更小 HCC 的中期临床结果。材料与方法:在这项多中心临床试验(NCT03375281)中,于 2017 年 11 月至 2019 年 1 月评估参与者的入选资格。纳入计划接受无接触 RFA 治疗的单个 2.5cm 或更小 HCC 的患者。记录成功进行无接触 RFA 的比例,定义为在不侵犯肿瘤本身的情况下进行 RFA。采用多变量逻辑回归分析确定无接触 RFA 失败的相关因素。还记录了无接触 RFA 后主要并发症的发生情况。采用 Kaplan-Meier 法估计局部肿瘤进展(LTP)和无复发生存率的累积发生率。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(128 名/140 名;91.4%)成功进行了无接触 RFA,由于缺乏安全的进入途径,12 名参与者改为肿瘤穿刺 RFA。通过使用无接触 RFA 或转为肿瘤穿刺 RFA,所有参与者均实现了 RFA 的技术成功,定义为消融区域完全覆盖靶肿瘤。肿瘤周围肝实质不足(肿瘤一半以上部分周围<5mm 宽度;比值比,74;95%CI:18,309;<.001)是无接触技术失败的唯一显著预测因素。在 140 名参与者中,有 2 名参与者发生 LTP,估计 1 年和 2 年 LTP 的累积发生率分别为 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细胞癌(≤2.5cm)的有效且安全的方法,2 年时累积 LTP 发生率为 1.6%。©RSNA,2021 本期 Soulen 和 García-Monaco 的社论亦有相关内容。

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