Department of Radiology, Seoul National University Hospital, Seoul, Korea.
Department of Radiology, Seoul National University College of Medicine, Seoul, Korea.
Korean J Radiol. 2021 Dec;22(12):1974-1984. doi: 10.3348/kjr.2021.0319. Epub 2021 Sep 24.
This study aimed to compare the efficacy between no-touch (NT) radiofrequency ablation (RFA) and conventional RFA using twin internally cooled wet (TICW) electrodes in the bipolar mode for the treatment of small hepatocellular carcinomas (HCC).
In this single-center, two-arm, parallel-group, prospective randomized controlled study, we performed a 1:1 random allocation of eligible patients with HCCs to receive NT-RFA or conventional RFA between October 2016 and September 2018. The primary endpoint was the cumulative local tumor progression (LTP) rate after RFA. Secondary endpoints included technical conversion rates of NT-RFA, intrahepatic distance recurrence, extrahepatic metastasis, technical parameters, technical efficacy, and rates of complications. Cumulative LTP rates were analyzed using Kaplan-Meier analysis and the Cox proportional hazard regression model. Considering conversion cases from NT-RFA to conventional RFA, intention-to-treat and as-treated analyses were performed.
Enrolled patients were randomly assigned to the NT-RFA group (37 patients with 38 HCCs) or the conventional RFA group (36 patients with 38 HCCs). Among the NT-RFA group patients, conversion to conventional RFA occurred in four patients (10.8%, 4/37). According to intention-to-treat analysis, both 1- and 3-year cumulative LTP rates were 5.6%, in the NT-RFA group, and they were 11.8% and 21.3%, respectively, in the conventional RFA group ( = 0.073, log-rank). In the as-treated analysis, LTP rates at 1 year and 3 years were 0% and 0%, respectively, in the NT-RFA group sand 15.6% and 24.5%, respectively, in the conventional RFA group ( = 0.004, log-rank). In as-treated analysis using multivariable Cox regression analysis, RFA type was the only significant predictive factor for LTP (hazard ratio = 0.061 with conventional RFA as the reference, 95% confidence interval = 0.000-0.497; = 0.004). There were no significant differences in the procedure characteristics between the two groups. No procedure-related deaths or major complications were observed.
NT-RFA using TICW electrodes in bipolar mode demonstrated significantly lower cumulative LTP rates than conventional RFA for small HCCs, which warrants a larger study for further confirmation.
本研究旨在比较使用双极模式下的双极内部冷却湿（TICW）电极的无接触（NT）射频消融（RFA）与传统 RFA 在治疗小肝细胞癌（HCC）方面的疗效。
这是一项单中心、双臂、平行组、前瞻性随机对照研究，我们将 2016 年 10 月至 2018 年 9 月期间符合条件的 HCC 患者以 1:1 的比例随机分配至 NT-RFA 或传统 RFA 治疗组。主要终点为 RFA 后累积局部肿瘤进展（LTP）率。次要终点包括 NT-RFA 的技术转化率、肝内距离复发、肝外转移、技术参数、技术疗效以及并发症发生率。采用 Kaplan-Meier 分析和 Cox 比例风险回归模型分析累积 LTP 率。考虑到 NT-RFA 转为传统 RFA 的病例，进行了意向治疗和实际治疗分析。
入组患者被随机分配至 NT-RFA 组（37 例患者 38 个 HCC）或传统 RFA 组（36 例患者 38 个 HCC）。在 NT-RFA 组中，有 4 例（10.8%，4/37）患者转为传统 RFA。根据意向治疗分析，NT-RFA 组的 1 年和 3 年累积 LTP 率分别为 5.6%，而传统 RFA 组分别为 11.8%和 21.3%（=0.073，对数秩检验）。在实际治疗分析中，NT-RFA 组的 1 年和 3 年 LTP 率分别为 0%和 0%，而传统 RFA 组分别为 15.6%和 24.5%（=0.004，对数秩检验）。在使用多变量 Cox 回归分析的实际治疗分析中，RFA 类型是唯一显著的 LTP 预测因素（传统 RFA 为参考，风险比=0.061，95%置信区间=0.000-0.497；=0.004）。两组的手术特征无显著差异。未观察到与手术相关的死亡或严重并发症。
使用 TICW 电极的双极模式下的 NT-RFA 与传统 RFA 相比，治疗小 HCC 的累积 LTP 率显著降低，需要进一步的大样本研究来证实。
