Sugimoto Katsutoshi, Imajo Kento, Kuroda Hidekatsu, Murohisa Go, Shiozawa Kazue, Sakamaki Kentaro, Wada Takuya, Takeuchi Hirohito, Endo Kei, Abe Tamami, Matsui Takashi, Murakami Takahiro, Yoneda Masato, Nakajima Atsushi, Kokubu Shigehiro, Itoi Takao
Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.
Department of Gastroenterology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
JHEP Rep. 2024 Nov 13;7(1):101269. doi: 10.1016/j.jhepr.2024.101269. eCollection 2025 Jan.
BACKGROUND & AIMS: Radiofrequency ablation (RFA) is the standard treatment for small hepatocellular carcinoma (HCC), specifically for tumors <3 cm in size and numbering fewer than three, excluding surgical candidates. Microwave ablation (MWA) is an innovative approach believed to have theoretical benefits over RFA; however, these advantages are yet to be empirically verified. Therefore, we evaluated and compared the effectiveness of MWA and RFA in managing HCC tumors up to 4 cm in size.
In this multicenter randomized controlled trial conducted across five centers in Japan, eligible participants had up to 4 tumors, each up to 4 cm in size, and were not considered for surgery. Patients were randomly assigned to undergo MWA or RFA. The primary outcome was the rate of local tumor progression (LTP), whereas secondary outcomes included overall survival (OS) and intra- and extrahepatic recurrence-free survival (RFS) at the end of the 2-year follow up.
In total, 240 participants were screened from July 12, 2018, to December 7, 2021. Four participants were excluded: three did not meet inclusion criteria, and one died from an unknown cause during treatment. Consequently, 119 (130 lesions) and 117 (136 lesions) participants were treated with MWA and RFA, respectively. The proportion of lesions with LTP at the 2-year follow up was significantly lower in the MWA group (20 [16.4%] lesions) than in the RFA group (38 [30.4%] lesions) (risk ratio, 0.54; = 0.007). OS and both intra- and extrahepatic RFS did not significantly differ between groups.
MWA is more effective than RFA in reducing local tumor progression for HCC tumors up to 4 cm. However, no differences were observed in OS and RFS.
While some randomized control trials (RCTs) have compared the efficacy of microwave ablation (MWA) and radiofrequency ablation (RFA) for small hepatocellular carcinoma (HCC), the superiority of MWA over RFA remains unverified despite its theoretical benefit. This study is the first to demonstrate the utility of MWA over single-needle RFA for patients with HCC, with a significant difference between the two groups in the proportion of lesions with local tumor progression after a 2-year follow up. Moreover, the two techniques were safe, with only two severe complications reported in the entire study cohort. Given that an RCT differs slightly from daily clinical situations, practical and anatomical criteria for selecting the optimal technique on a lesion-by-lesion basis are required.
射频消融（RFA）是小肝细胞癌（HCC）的标准治疗方法，特别适用于直径小于3 cm且数量少于3个、不适合手术的肿瘤。微波消融（MWA）是一种创新方法，被认为在理论上优于RFA；然而，这些优势尚未得到实证验证。因此，我们评估并比较了MWA和RFA治疗直径达4 cm的HCC肿瘤的有效性。
在日本五个中心进行的这项多中心随机对照试验中，符合条件的参与者有多达4个肿瘤，每个肿瘤直径达4 cm，且不考虑手术治疗。患者被随机分配接受MWA或RFA。主要结局是局部肿瘤进展（LTP）率，次要结局包括2年随访结束时的总生存期（OS）以及肝内和肝外无复发生存期（RFS）。
从2018年7月12日至2021年12月7日，共筛选出240名参与者。4名参与者被排除：3名不符合纳入标准，1名在治疗期间因不明原因死亡。因此，分别有119名（130个病灶）和117名（136个病灶）参与者接受了MWA和RFA治疗。MWA组在2年随访时LTP病灶的比例（20个[16.4%]病灶）显著低于RFA组（38个[30.4%]病灶）（风险比，0.54；P = 0.007）。两组之间的OS以及肝内和肝外RFS没有显著差异。
对于直径达4 cm的HCC肿瘤，MWA在减少局部肿瘤进展方面比RFA更有效。然而，在OS和RFS方面未观察到差异。
虽然一些随机对照试验（RCT）比较了微波消融（MWA）和射频消融（RFA）治疗小肝细胞癌（HCC）的疗效，但尽管MWA有理论优势，其优于RFA的结论仍未得到验证。本研究首次证明了MWA对于HCC患者优于单针RFA，两组在2年随访后局部肿瘤进展病灶比例上有显著差异。此外，这两种技术都很安全，整个研究队列中仅报告了两例严重并发症。鉴于RCT与日常临床情况略有不同，需要基于逐个病灶选择最佳技术的实用和解剖学标准。
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