Department of Radiology, Seoul National University Hospital, Seoul, Korea.
Department of Radiology, Seoul National University College of Medicine, Seoul, Korea.
PLoS One. 2020 Sep 28;15(9):e0239733. doi: 10.1371/journal.pone.0239733. eCollection 2020.
This study aimed to compare the efficacy between bipolar radiofrequency ablation (RFA), using twin internally cooled wet (TICW) electrodes, and switching monopolar RFA, using separable clustered (SC) electrodes, in the treatment of recurrent hepatocellular carcinoma (HCC) after locoregional treatment.
In this single-center, two-arm, parallel-group, randomized controlled study, we performed a 1:1 random allocation on eligible patients with recurrent HCC after locoregional treatment, to receive TICW-RFA or SC-RFA. The primary endpoint was the minimum diameter of the ablation zone per unit ablation time. Secondary endpoints included other technical parameters, complication rate, technical success and technique efficacy, and clinical outcomes.
Enrolled patients were randomly assigned to the TICW-RFA group (n = 40) or SC-RFA group (n = 37). The two groups did not show significant differences in the primary endpoint, the minimum diameter of the ablation zone per unit ablation time was 2.71 ± 0.98 mm/min and 2.61 ± 0.96 mm/min in the TICW-RFA and SC-RFA groups, respectively (p = 0.577). Total RF energy delivery (11.75 ± 9.04 kcal vs. 22.61 ± 12.98 kcal, p < 0.001) and energy delivery per unit time (0.81 ± 0.49 kcal/min vs. 1.45 ± 0.42 kcal/min, p < 0.001) of the TICW-RFA group were less than those of the SC-RFA group. No procedure-related death or major complications occurred. Technical success was achieved in all patients in both groups, and technique efficacy rates were 100% (46/46) in the TICW-RFA group and 95.0% (38/40) in the SC-RFA group (p = 0.213). The 1-year and 2-year cumulative LTP rates were 11.8% and 24.2%, respectively, in the TICW-RFA group, and 8.6% and 18.1%, respectively, in the SC-RFA group (p = 0.661).
In this single-center randomized controlled study from a Korean tertiary referral hospital, TICW-RFA demonstrated similar therapeutic efficacy and safety profile for recurrent HCC after locoregional treatment compared with SC-RFA.
ClinicalTrials.gov (NCT03806218).
本研究旨在比较双极射频消融（RFA）联合使用双极内部冷却湿电极（TICW）与单极切换 RFA 联合使用可分离簇集电极（SC）治疗局部治疗后复发性肝细胞癌（HCC）的疗效。
这是一项单中心、两臂、平行组、随机对照研究，我们对局部治疗后复发的 HCC 患者进行了 1:1 随机分组，接受 TICW-RFA 或 SC-RFA 治疗。主要终点是单位消融时间的消融区最小直径。次要终点包括其他技术参数、并发症发生率、技术成功率和技术疗效以及临床结果。
入组患者被随机分配至 TICW-RFA 组（n = 40）或 SC-RFA 组（n = 37）。两组在主要终点方面无显著差异，TICW-RFA 和 SC-RFA 组的消融区最小直径分别为 2.71 ± 0.98mm/min 和 2.61 ± 0.96mm/min（p = 0.577）。TICW-RFA 组的总 RF 能量输送（11.75 ± 9.04kcal 比 22.61 ± 12.98kcal，p < 0.001）和单位时间能量输送（0.81 ± 0.49kcal/min 比 1.45 ± 0.42kcal/min，p < 0.001）均低于 SC-RFA 组。两组均无与操作相关的死亡或重大并发症发生。两组患者均达到了技术成功，TICW-RFA 组的技术疗效率为 100%（46/46），SC-RFA 组为 95.0%（38/40）（p = 0.213）。TICW-RFA 组的 1 年和 2 年累积局部肿瘤无进展率分别为 11.8%和 24.2%，SC-RFA 组分别为 8.6%和 18.1%（p = 0.661）。
在这项来自韩国一家三级转诊医院的单中心随机对照研究中，TICW-RFA 治疗局部治疗后复发性 HCC 的疗效和安全性与 SC-RFA 相似。
ClinicalTrials.gov（NCT03806218）。
