Radiofrequency ablation versus ethanol injection for early hepatocellular carcinoma: A randomized controlled trial
Radiofrequency ablation versus ethanol injection for early hepatocellular carcinoma: A randomized controlled trial
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DOI：
10.1080/00365520701885481
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发表时间：
2008-01-01
影响因子：
1.9
通讯作者：
Rizzetto, Mario
中科院分区：
文献类型：
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作者：
Brunello, Franco;Veltri, Andrea;Rizzetto, Mario
目的：比较经皮乙醇注射（PEI）和射频消融（RFA），前者是多年来用于治疗肝硬化患者早期非手术肝细胞癌（HCC）的标准方法，后者已成为一种令人关注的替代方法。
材料与方法：对139例Child - Pugh A/B级肝硬化且有1 - 3个肝细胞癌结节（直径15 - 30mm）的患者进行了一项随机试验，共有177个病灶。患者被随机分为接受RFA组（n = 70）或PEI组（n = 69）。主要终点是基线时确定的所有肝细胞癌结节经皮消融1年后的完全缓解（CR）。次要终点包括：早期（30 - 50天）完全缓解、并发症、生存率和费用。
结果：在意向性分析中，接受RFA和PEI治疗的患者分别有46/70（65.7%）和25/69（36.2%）在1年后达到完全缓解（p = 0.0005）。对于直径>20mm的病灶，RFA组的完全缓解率更高（68.1%对26.3%）。接受RFA治疗的患者中有67/70（95.7%）获得早期完全缓解，而接受PEI治疗的患者中有42/64（65.6%）获得早期完全缓解（p = 0.0001）。RFA组和PEI组分别有10例和12例患者出现并发症。RFA组与PEI组的总体生存率无显著差异（校正风险比 = 0.88，95%置信区间：0.50 - 1.53）。每多一名成功接受RFA治疗的患者，医疗费用增加8286 sic。
结论：早期肝细胞癌经皮治疗后1年完全缓解率RFA显著优于PEI，但在肝硬化患者中未提供明显的生存优势。
Objective. To compare percutaneous ethanol injection (PEI), the standard approach which has been used for many years to treat early non-surgical hepatocellular carcinoma (HCC) in cirrhotic patients, and radiofrequency ablation (RFA), which has become an interesting alternative. Material and methods. A randomized trial was carried out on 139 cirrhotic patients in Child-Pugh classes A/B with 1-3 nodes of HCC (diameter 15-30 mm), for a total of 177 lesions. Patients were randomized to receive RFA (n=70) or PEI (n=69). The primary end-point was complete response (CR) 1 year after the percutaneous ablation of all HCC nodes identified at baseline. Secondary end-points were: early (30-50 days) CR, complications, survival and costs. Results. In an intention-to-treat analysis, 1-year CR was achieved in 46/70 (65.7%) and in 25/69 (36.2%) patients treated by RFA and PEI, respectively (p=0.0005). For lesions >20 mm in diameter, there was a larger CR rate in the RFA group (68.1% versus 26.3%). An early CR was obtained in 67/70 (95.7%) patients treated by RFA compared with 42/64 (65.6%) patients treated by PEI (p=0.0001). Complications occurred in 10 and 12 patients treated by RFA and PEI, respectively. The overall survival rate was not significantly different in the RFA versus PEI arm (adjusted hazard ratio=0.88, 95% CI: 0.50-1.53). There was an incremental health-care cost of 8286 sic for each additional patient successfully treated by RFA. Conclusions. The 1-year CR rate after percutaneous treatment of early HCC was significantly better with RFA than with PEI but did not provide a clear survival advantage in cirrhotic patients.