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Radiofrequency Ablation Using a Separable Clustered Electrode for the Treatment of Hepatocellular Carcinomas: A Randomized Controlled Trial of a Dual-Switching Monopolar Mode Versus a Single-Switching Monopolar Mode

Korean Journal of Radiology 2021년 22권 2호 p.179 ~ 188
최재원, 이정민, 이동훈, 윤정환, 김윤준, 이정훈, 유수종, 조은주,
소속 상세정보
최재원 ( Choi Jae-Won ) - Seoul National University Hospital Department of Radiology
이정민 ( Lee Jeong-Min ) - Seoul National University Hospital Department of Radiology
이동훈 ( Lee Dong-Hoon ) - Seoul National University Hospital Department of Radiology
윤정환 ( Yoon Jung-Hwan ) - Seoul National University Hospital Department of Internal Medicine
김윤준 ( Kim Yoon-Jun ) - Seoul National University Hospital Department of Internal Medicine
이정훈 ( Lee Jeong-Hoon ) - Seoul National University Hospital Department of Internal Medicine
유수종 ( Yu Su-Jong ) - Seoul National University Hospital Department of Internal Medicine
조은주 ( Cho Eun-Ju ) - Seoul National University Hospital Department of Internal Medicine

Abstract


Objective: This study aimed to prospectively compare the efficacy, safety, and mid-term outcomes of dual-switching monopolar (DSM) radiofrequency ablation (RFA) to those of conventional single-switching monopolar (SSM) RFA in the treatment of hepatocellular carcinoma (HCC).

Materials and Methods: This single-center, two-arm, parallel-group, randomized controlled study was approved by the Institutional Review Board. Written informed consent was obtained from all patients upon enrollment. A total of 80 patients with 94 HCC nodules were randomized into either the DSM-RFA group or SSM-RFA group in a 1:1 ratio, using a blocked randomization method (block size 2). The primary endpoint was the minimum diameter of the ablation zone per unit time. The secondary endpoints included other technical parameters, complication rate, technique efficacy, and 2-year clinical outcomes.

Results: Significantly higher ablation energy per unit time was delivered to the DSM-RFA group than to the SSM-RFA group (1.7 ± 0.2 kcal/min vs. 1.2 ± 0.3 kcal/min; p < 0.001). However, no significant differences were observed between the two groups for the analyzed variables, including primary endpoint, regarding size of the ablation zone and ablation time. Major complication rates were 4.9% in the DSM-RFA group and 2.6% in the SSM-RFA group (p = 1.000). The 2-year local tumor progression (LTP) rates of the HCC nodules treated using DSM-RFA and SSM-RFA were 8.5% and 4.7%, respectively (p = 0.316). The 2-year LTP-free survival rates of patients in the DSM-RFA and SSM-RFA groups were 90.0% and 94.4%, respectively (p = 0.331), and the 2-year recurrence-free survival rates were 54.9% and 75.7%, respectively (p = 0.265).

Conclusion: Although DSM-RFA using a separable clustered electrode delivers higher ablation energy than SSM-RFA, its effectiveness failed to show superiority over SSM-RFA in the treatment of HCC.

키워드

Hepatocellular carcinoma; Radiofrequency ablation; Randomized controlled trial

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