Department of Radiology, Seoul Veterans Hospital, Seoul, Korea.
Hepatology. 2010 Apr;51(4):1284-90. doi: 10.1002/hep.23466.
No adequate randomized trials have been reported for a comparison between hepatic resection (HR) versus radiofrequency ablation (RFA) for the treatment of patients with very early stage hepatocellular carcinoma (HCC), defined as an asymptomatic solitary HCC <2 cm. For compensated cirrhotic patients with very early stage HCC, a Markov model was created to simulate a randomized trial between HR (group I) versus primary percutaneous RFA followed by HR for cases of initial local failure (group II) versus percutaneous RFA monotherapy (group III); each arm was allocated with a hypothetical cohort of 10,000 patients. The primary endpoint was overall survival. The estimates of the variables were extracted from published articles after a systematic review. In the parameter estimations, we assumed the best scenario for HR and the worst scenario for RFA. The mean expected survival was 7.577 years, 7.564 years, and 7.356 years for group I, group II, and group III, respectively. One-way sensitivity analysis demonstrated that group II was the preferred strategy if the perioperative mortality rate was greater than 1.0%, if the probability of local recurrence following an initial complete ablation was <1.9% or if the positive microscopic resection margin rate was >0.3%. The 95% confidence intervals for the difference in overall survival were -0.18-0.18 years between group I and II, 0.06-0.36 years between group I and III, and 0.13-0.30 years between group II and III, respectively.
Primary percutaneous RFA followed by HR for cases of initial local failure was nearly identical to HR for the overall survival of compensated cirrhotic patients with very early stage HCC.
尚无充分的随机试验比较肝切除术(HR)与射频消融术(RFA)治疗小肝癌(HCC)患者,小肝癌定义为无症状单发 HCC<2cm。对于代偿性肝硬化合并小肝癌患者,建立 Markov 模型模拟 HR(I 组)与初始局部失败后行 HR(II 组)、RFA 单药治疗(III 组)之间的随机试验,每组分配 10000 例患者。主要终点为总生存。采用系统评价提取发表文献中变量的估计值。参数估计中,假设 HR 为最佳方案,RFA 为最差方案。I 组、II 组和 III 组的平均预期生存时间分别为 7.577 年、7.564 年和 7.356 年。单因素敏感性分析显示,若围手术期死亡率>1.0%,初始完全消融后局部复发率<1.9%或切缘阳性率>0.3%,则 II 组为首选策略。I 组与 II 组、I 组与 III 组、II 组与 III 组总生存差异的 95%可信区间分别为-0.18~0.18 年、0.06~0.36 年、0.13~0.30 年。
对于代偿性肝硬化合并小肝癌患者,初始局部失败后行经皮 RFA 联合 HR 与 HR 治疗的总生存相似。