Laser Ablation Versus Radiofrequency Ablation for Benign Non-Functioning Thyroid Nodules: Six-Month Results of a Randomized, Parallel, Open-Label, Trial (LARA Trial)
Laser Ablation Versus Radiofrequency Ablation for Benign Non-Functioning Thyroid Nodules: Six-Month Results of a Randomized, Parallel, Open-Label, Trial (LARA Trial)
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DOI：
10.1089/thy.2019.0660
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发表时间：
2020-03-17
期刊：
影响因子：
6.6
通讯作者：
Palermo, Andrea
中科院分区：
文献类型：
--
作者：
Cesareo, Roberto;Pacella, Claudio Maurizio;Palermo, Andrea
背景资料：目前尚无比较激光消融（LA）和射频消融（RFA）用于良性无功能甲状腺结节（BNTN）减积的直接前瞻性研究。我们的目的是比较两种技术的疗效和安全性，在患者与固体或主要固体BNTN.Methods：这六个月，单次使用，随机，开放标签，平行试验比较了以下主要终点之间的RFA和LA组治疗后六个月：（i）结节体积减少表示为结节体积的百分比在基线;（ii）减少50%以上的结节比例（成功率）。我们招募了具有以压力症状/美容问题为特征的孤立性BNTN或显性结节的受试者，或在一年内经历体积增加>20%的无症状患者。结节行粗针穿刺活检诊断。患者被随机分配（1：1）接受LA或RFA。结果：60例患者在2016年1月至2018年11月期间被随机分配接受RFA或LA（1：1）。两组在基底结节体积、甲状腺功能、组织学、症状/美容评分和手术时间方面相似。6个月时，RFA组的结节体积缩小率为64.3%（95%置信区间，CI 57.5-71.2），LA组为53.2%（[CI 47.2-95.2]; p = 0.02）。在针对年龄、基线体积和细胞成分比例调整的线性回归模型中也证实了该效应（LA与RFA百分比变化Δ =-12.8，p = 0.02）。治疗后6个月的成功率（RFA vs. LA：86.7% vs. 66.7%，p = 0.13）或促甲状腺激素水平在两组之间无显著差异。尽管有所改善，但在压迫症状（RFA：2.13 vs. 3.9，p < 0，中心点001; LA：2.4 vs. 3.87，p < 0.001）和外观评分（RFA：1.65 vs. 2.2，p < 0.001; LA：1.85 vs. 2.2，p < 0.001）方面，没有观察到RFA和LA之间的显著差异。RFA和LA的不良事件发生率（局部疼痛，发音困难，甲状腺毒症，发热，血肿）分别为37%（n = 11）和43%（n = 13），无需住院治疗。结论：虽然RFA和LA组的成功率相似，但RFA在6个月时实现了显著更大的结节体积缩小。
Background: No direct prospective studies comparing laser ablation (LA) and radiofrequency ablation (RFA) for debulking benign non-functioning thyroid nodules (BNTNs) exist. We aimed at comparing the efficacy and safety of both techniques in patients with solid or predominantly solid BNTN.Methods: This six-month, single-use, randomized, open-label, parallel trial compared the following primary endpoints between the RFA and LA groups six months after treatment: (i) nodule volume reduction expressed as a percentage of nodule volume at baseline; (ii) proportion of nodules with more than 50% reduction (successful rate). We enrolled subjects with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems or patients without symptoms who experienced a volume increase >20% in one year. Nodules underwent core needle biopsy for diagnosis. Patients were randomly assigned (1:1) to receive LA or RFA. Safety was assessed in all randomly assigned participants.Results: Sixty patients were randomly assigned to receive either RFA or LA (1:1) between January 2016 and November 2018. Both groups were similar in basal nodule volume, thyroid function, histology, symptoms/cosmetic score, and procedure time. At six months, the nodule volume reduction was 64.3% (95% confidence interval, CI 57.5-71.2) in the RFA group and 53.2% ([CI 47.2-95.2]; p = 0.02) in the LA group. This effect was also confirmed in the linear regression model adjusted for age, baseline volume, and proportion of cellular component (LA vs. RFA percent change Delta = -12.8, p = 0.02). No significant difference was observed in success rate six months after treatment (RFA vs. LA: 86.7% vs. 66.7%, p = 0.13) or in thyrotropin level between the groups. Although improved, no significant difference was observed between RFA and LA for compressive symptoms (RFA: 2.13 vs. 3.9, p < 0 center dot 001; LA: 2.4 vs. 3.87, p < 0.001) and cosmetic score (RFA: 1.65 vs. 2.2, p < 0.001; LA: 1.85 vs. 2.2, p < 0.001). The adverse event rates (local pain, dysphonia, thyrotoxicosis, fever, hematoma) were 37% (n = 11) and 43% (n = 13) for RFA and LA, respectively, with no requirement for hospitalization.Conclusion: Although the success rate was similar in the RFA and LA groups, RFA achieved a significantly larger nodule volume reduction at six months.