Introduction: It remains unclear which of surgery or radiofrequency ablation (RFA) is the more effective treatment for small hepatocellular carcinoma (HCC). We aimed to compare survival between patients undergoing surgery (surgery group) and patients undergoing RFA (RFA group). Methods: We conducted a randomized controlled trial involving 49 institutions in Japan. Patients with Child-Pugh scores ≤ 7, largest HCC diameter ≤ 3 cm, and ≤ 3 HCC nodules were considered eligible. The co-primary endpoints were recurrence-free survival (RFS) and overall survival (OS). The current study reports the final result of RFS, and the follow-up of OS is still ongoing. Results: During 2009–2015, 308 patients were registered. After excluding ineligible patients, the surgery and RFA groups included 150 and 151 patients, respectively. Baseline factors did not differ significantly between the groups. In both groups, 90% of patients had solitary HCC. The median largest HCC diameter was 1.8 cm (interquartile range, 1.5–2.2 cm) in the surgery group and 1.8 cm (interquartile range, 1.5–2.3 cm) in the RFA group. The median procedure duration (274 versus 40 minutes, P<0.01) and the median duration of hospital stay (17 days versus 10 days, P<0.01) were longer in the surgery group than in the RFA group. RFS did not differ significantly between the groups as the median RFS was 3.5 (95% confidence interval [CI], 2.6–5.1) years in the surgery group and 3.0 (95% CI, 2.4–5.6) years in the RFA group (hazard ratio, 0.92; 95% CI, 0.67–1.25; P=0.58). Discussion/Conclusion: Our study did not show which of surgery or RFA is the better treatment option for small HCC.


中文翻译：

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小肝癌的手术与射频消融：随机对照试验（SURF-试验）

简介：目前尚不清楚哪种手术或射频消融 (RFA) 是小肝细胞癌 (HCC) 更有效的治疗方法。我们旨在比较接受手术的患者（手术组）和接受 RFA 的患者（RFA 组）的生存率。方法：我们在日本进行了一项涉及 49 家机构的随机对照试验。Child-Pugh 评分 ≤ 7、最大 HCC 直径 ≤ 3 cm 和 ≤ 3 个 HCC 结节的患者被认为是合格的。共同主要终点是无复发生存期（RFS）和总生存期（OS）。目前的研究报告了RFS的最终结果，OS的随访仍在进行中。结果：2009-2015 年间，登记了 308 名患者。排除不合格患者后，手术组和 RFA 组分别包括 150 和 151 名患者。基线因素在各组之间没有显着差异。在两组中，90% 的患者患有孤立性 HCC。手术组的最大 HCC 直径中位数为 1.8 cm（四分位距，1.5-2.2 cm），RFA 组为 1.8 cm（四分位距，1.5-2.3 cm）。手术组的中位手术时间（274 对 40 分钟，P<0.01）和中位住院时间（17 天对 10 天，P<0.01）长于 RFA 组。RFS 在各组之间没有显着差异，因为手术组的中位 RFS 为 3.5（95% 置信区间 [CI]，2.6-5.1）年，而 RFA 组为 3.0（95% CI，2.4-5.6）年（危险比率，0.92；95% CI，0.67–1.25；P=0.58）。讨论/结论：我们的研究没有表明手术或 RFA 是小 HCC 的更好治疗选择。