Department of Radiology and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Department of Radiology and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Lancet Gastroenterol Hepatol. 2018 May;3(5):317-325. doi: 10.1016/S2468-1253(18)30029-3. Epub 2018 Mar 2.
Radiofrequency ablation is the recommended treatment for patients with hepatocellular carcinoma who have lesions smaller than 3 cm and are therefore not candidates for surgery. Microwave ablation is a more recent technique with certain theoretical advantages that have not yet been confirmed clinically. We aimed to compare the efficacy of both techniques in the treatment of hepatocellular carcinoma lesions of 4 cm or smaller.
We did a randomised controlled, single-blinded phase 2 trial at four tertiary university centres in France and Switzerland. Patients with chronic liver disease and hepatocellular carcinoma with up to three lesions of 4 cm or smaller who were not eligible for surgery were randomised to receive microwave ablation (experimental group) or radiofrequency ablation (control group). Randomisation was centralised and done by use of a fixed block method (block size 4). Patients were randomly assigned by a co-investigator by use of the sealed opaque envelope method and were masked to the treatment; physicians were not masked to treatment, since the devices used were different. The primary outcome was the proportion of lesions with local tumour progression at 2 years of follow-up. Local tumour progression was defined as the appearance of a new nodule with features typical of hepatocellular carcinoma in the edge of the ablation zone. All analyses were done in the per-protocol population. The study is completed, but patients will continue to be followed up for 5 years. This study is registered with ClinicalTrials.gov, number NCT02859753.
Between Nov 15, 2011, and Feb 27, 2015, 152 patients were randomly assigned: 76 patients to receive microwave ablation and 76 patients to receive radiofrequency ablation. For the per-protocol analysis, five patients were excluded from the microwave ablation group as were three patients from the radiofrequency ablation group. Median follow-up was 26 months (IQR 18-29) in the microwave ablation group and 25 months (18-34) in the radiofrequency ablation group. At 2 years, six (6%) of 98 lesions had local tumour progression in the microwave ablation group as did 12 (12%) of 104 in the radiofrequency ablation group (risk ratio 1·62, 95% CI 0·66-3·94; p=0·27). Complications were infrequent, with only two grade 4 complications (two events of arterial bleeding requiring embolisation, both in the microwave ablation group) and three grade 3 complications (pneumothorax; lesion of the umbilical vein; and intrahepatic segmental necrosis, all in the radiofrequency ablation group). No treatment-related deaths were reported.
Although we did not find that microwave ablation was more effective than radiofrequency ablation for treatment of hepatocellular carcinoma lesions of 4 cm or smaller, our results show that the proportion of lesions with local tumour progression at 2 years of follow-up was low with both tested percutaneous methods.
Microsulis (AngioDynamics).
射频消融是治疗直径小于 3cm 且不适合手术的肝细胞癌患者的首选方法。微波消融是一种较新的技术，具有某些尚未在临床上得到证实的理论优势。我们旨在比较两种技术在治疗直径为 4cm 或更小的肝细胞癌病灶中的疗效。
我们在法国和瑞士的四家三级大学中心进行了一项随机对照、单盲、2 期临床试验。患有慢性肝病和不适合手术的最大 3 个直径为 4cm 或更小的肝细胞癌病灶的患者被随机分为微波消融（实验组）或射频消融（对照组）组。采用中央随机化和固定块方法（块大小为 4）进行随机分组。患者由共同研究者通过密封的不透明信封方法随机分配，对治疗情况设盲；由于使用的设备不同，医生对治疗情况不设盲。主要结局是在 2 年随访时局部肿瘤进展的病灶比例。局部肿瘤进展定义为消融区域边缘出现新的具有肝细胞癌特征的结节。所有分析均在符合方案人群中进行。该研究已经完成，但患者将继续随访 5 年。本研究在 ClinicalTrials.gov 注册，编号为 NCT02859753。
2011 年 11 月 15 日至 2015 年 2 月 27 日期间，共有 152 名患者被随机分配：76 名患者接受微波消融，76 名患者接受射频消融。在符合方案分析中，微波消融组有 5 名患者和射频消融组有 3 名患者被排除。微波消融组的中位随访时间为 26 个月（IQR 18-29），射频消融组为 25 个月（18-34）。在 2 年时，微波消融组有 6 个（6%）98 个病灶发生局部肿瘤进展，射频消融组有 12 个（12%）104 个病灶发生局部肿瘤进展（风险比 1.62，95%CI 0.66-3.94；p=0.27）。并发症少见，仅 2 例为 4 级并发症（均为微波消融组动脉出血需栓塞的事件）和 3 例 3 级并发症（气胸；脐静脉损伤；肝内节段性坏死，均为射频消融组）。未报告与治疗相关的死亡。
尽管我们没有发现微波消融在治疗直径为 4cm 或更小的肝细胞癌病灶方面比射频消融更有效，但我们的结果表明，两种经皮治疗方法在 2 年随访时局部肿瘤进展的病灶比例均较低。
Microsulis（AngioDynamics）。
