Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study)
Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study)
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DOI：
10.1210/clinem/dgab102
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发表时间：
2021-02-20
影响因子：
5.8
通讯作者：
Palermo, Andrea
中科院分区：
文献类型：
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作者：
Cesareo, Roberto;Manfrini, Silvia;Palermo, Andrea
背景：在良性无功能甲状腺结节 (BNTN) 中，射频消融 (RFA) 似乎比激光消融 (LA) 实现了显着更大的结节体积缩小率 (VRR) 目的：比较两种治疗方法在 12 个月随访中对实性或主要实性 BNTN 患者的疗效和安全性。 方法：这是一项在门诊患者中进行的单中心、12 个月、随机、优越性、开放标签、平行组试验诊所。 60 名患有孤立性 BNTN 或以压力症状/外观问题为特征的显性结节的患者被随机分配（1:1 比例）接受单次 RFA 或 LA。每组 29 名患者完成了研究。主要结果指标是 VRR 和缩小超过 50% 的结节比例（技术成功率）。结果：12 个月时，RFA 组和 LA 组的 VRR 分别为 70.9 +/- 16.9% 和 60.0 +/- 19.0% (P =.024)。这种效应在线性回归模型中得到了证实，该模型根据年龄、性别、结节基线体积和细胞成分比例进行了调整（RFA 治疗：β = .390；P = .009）。治疗后 12 个月的技术成功率没有观察到显着的组间差异。从基线到 12 个月的随访观察到压缩有统计学上的显着改善（RFA：4.6 +/- 2.6 和 1.3 +/- 0.8，P
Context: Radiofrequency ablation (RFA) seems to achieve a significantly larger nodule volume reduction rate (VRR) than laser ablation (LA) in benign nonfunctioning thyroid nodules (BNTNs)Objective: To compare the efficacy and safety of both treatments at 12-month follow-up in patients with solid or predominantly solid BNTN.Methods: This was a single-center, 12-month, randomized, superiority, open-label, parallel-group trial conducted in an outpatient clinic. Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems were randomly assigned (1:1 ratio) to receive either a single session of RFA or LA. Twenty-9 patients per group completed the study. The main outcome measures were VRR and proportion of nodules with more than 50% reduction (technical success rate).Results: At 12 months, VRR was 70.9 +/- 16.9% and 60.0 +/- 19.0% in the RFA and LA groups, respectively (P =.024). This effect was confirmed in the linear regression model that was adjusted for age, sex, nodule baseline volume, and proportion of cellular components (RFA treatment: beta =.390; P =.009). No significant between-group difference was observed in the technical success rate at 12 months after treatment. A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 +/- 2.6 and 1.3 +/- 0.8, P