Shibata Toshiya, Shibata Toyomichi, Maetani Yoji, Isoda Hiroyoshi, Hiraoka Masahiro
Department of Radiology, Kyoto University Graduate School of Medicine, 54-Kawaharacho, Shogoin, Sakyoku, Kyoto 606-8507, Japan.
Radiology. 2006 Jan;238(1):346-53. doi: 10.1148/radiol.2381041848.
To prospectively compare the effectiveness of radiofrequency (RF) ablation performed by using an internally cooled electrode and an expandable electrode for the treatment of small (< or = 3.0 cm) hepatocellular carcinomas (HCCs).
The human subjects research review board at the study institution approved the protocol, and each patient provided informed consent. Seventy-four patients (58 men and 16 women; age range, 41-83 years) with 83 HCC nodules 3 cm or smaller were randomly divided into an internally cooled electrode group (38 patients with 41 nodules) and an expandable electrode group (36 patients with 42 nodules). RF ablation was performed by one individual. Primary technique effectiveness and rates of major complications were evaluated between the two groups with the Fisher exact test. Rates of local tumor progression, overall survival, local progression-free survival, and event-free survival were evaluated by using the Kaplan-Meier method.
The primary technique effectiveness was 95% in the internally cooled electrode group and 93% in the expandable electrode group (P = .51); rates of major complications were 0% and 2.1% per session (P = .50) and 0% and 2.8% per patient (P = .49), respectively. Rates at 1, 2, and 3 years in the internally cooled electrode group versus the expandable electrode group were as follows: local tumor progression, 12% versus 17%, 20% versus 22%, and 20% versus 22% (P = .72, log-rank test); overall survival, 100% versus 94%, 94% versus 92%, and 94% versus 77% (P = .29, log-rank test); local progression-free survival, 87% versus 78%, 73% versus 66%, and 73% versus 46% (P = .27, log-rank test); and event-free survival, 47% versus 44%, 34% versus 22%, and 34% versus 22% (P = .40, log-rank test).
On the basis of the study findings, RF ablation with an internally cooled electrode needle and an expandable electrode needle has equivalent effectiveness for the treatment of small HCCs.
前瞻性比较使用内部冷却电极和可扩张电极进行射频（RF）消融治疗小（≤3.0 cm）肝细胞癌（HCC）的有效性。
研究机构的人体研究审查委员会批准了该方案，每位患者均提供了知情同意书。74例患者（58例男性和16例女性；年龄范围41 - 83岁），共83个直径3 cm及以下的HCC结节，被随机分为内部冷却电极组（38例患者，41个结节）和可扩张电极组（36例患者，42个结节）。由一名医生进行RF消融。两组间主要技术有效性和主要并发症发生率采用Fisher精确检验进行评估。局部肿瘤进展率、总生存率、局部无进展生存率和无事件生存率采用Kaplan-Meier法进行评估。
内部冷却电极组的主要技术有效性为95%，可扩张电极组为93%（P = 0.51）；每次治疗的主要并发症发生率分别为0%和2.1%（P = 0.50），每位患者的发生率分别为0%和2.8%（P = 0.49）。内部冷却电极组与可扩张电极组在1年、2年和3年时的发生率如下：局部肿瘤进展率，分别为12%对17%、20%对22%、20%对22%（P = 0.72，对数秩检验）；总生存率，分别为100%对94%、94%对92%、94%对77%（P = 0.29，对数秩检验）；局部无进展生存率，分别为87%对78%、73%对66%、73%对46%（P = 0.27，对数秩检验）；无事件生存率，分别为47%对44%、34%对22%、34%对22%（P = 0.40，对数秩检验）。
基于研究结果，使用内部冷却电极针和可扩张电极针进行RF消融治疗小HCC的有效性相当。
