Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Department of Radiology, Gangneung Asan Medical Center, Ulsan University College of Medicine, Gangneung, Korea.
Thyroid. 2024 Sep;34(9):1126-1136. doi: 10.1089/thy.2024.0098.
Active surveillance (AS) of papillary thyroid microcarcinomas (PTMC) is emerging as an alternative to immediate surgery. While thermal ablation has also shown promise for low-risk PTMC, it has not been prospectively studied in patients appropriate for AS. This study aimed to evaluate the efficacy and safety of ultrasound (US)-guided radiofrequency ablation (RFA) for tumor control and quality of life (QoL) management in patients with PTMC who favored AS over immediate surgery. This prospective clinical trial was conducted at a single tertiary referral hospital from 2018 to 2021. Of 227 adult patients aged ≤60 years with low-risk unifocal PTMC favoring AS over immediate surgery, 100 patients underwent RFA for their management. The primary endpoint was the disease progression rate, and secondary endpoints were technical success, volume reduction rate (VRR), complication rates, and QoL. The median age of the study population was 42 years (range, 27-59 years), and 83% (83/100, [CI: 66.1-100]) were female. The median follow-up was 30 months (range, 12-56 months). All 100 patients underwent RFA with technical success. Most of the ablation zones showed continuous volume reduction, and 95.9% (94/98, [CI: 77.5-100.0]) showed complete disappearance at the last follow-up. The median VRR was 100.0% at 1-year follow-up and persisted throughout the last follow-up. The cumulative disease progression rate among 98 patients who underwent at least 1-year follow-up was 3.1% (3/98, [CI: 0.6-9.0]); one patient had lymph node metastasis (treated with surgery), and two patients had new PTMC (1 treated with RFA, 1 ongoing AS). Major complications were not observed. Psychological (baseline vs. last follow-up, 7.3 vs. 8.0, = 0.002) and social (8.0 vs. 8.7, = 0.005) QoL scores significantly improved during follow-up without compromising physical QoL (8.6 vs. 8.5, = 0.99). RFA can be a reasonable strategy for effectively and safely controlling tumors and improving QoL in non-elderly patients with low-risk PTMC appropriate for AS. Clinical Trial registration: This trial is registered with ClinicalTrials.gov: NCT03432299.
主动监测（AS）甲状腺微小乳头状癌（PTMC）正逐渐成为一种替代即刻手术的方法。虽然热消融术也已显示出对低危 PTMC 的疗效，但尚未在适合 AS 的患者中进行前瞻性研究。本研究旨在评估超声（US）引导下射频消融（RFA）治疗适合 AS 而非即刻手术的低危单发 PTMC 患者的肿瘤控制和生活质量（QoL）管理的疗效和安全性。 这项前瞻性临床试验于 2018 年至 2021 年在一家三级转诊医院进行。227 名年龄≤60 岁的低危单发 PTMC 成年患者倾向于 AS 而非即刻手术，其中 100 名患者接受 RFA 治疗。主要终点是疾病进展率，次要终点是技术成功率、体积减少率（VRR）、并发症发生率和 QoL。 研究人群的中位年龄为 42 岁（范围，27-59 岁），83%（83/100，[CI：66.1-100]）为女性。中位随访时间为 30 个月（范围，12-56 个月）。所有 100 名患者均成功接受 RFA 治疗。大多数消融区显示出持续的体积减少，95.9%（94/98，[CI：77.5-100.0]）在最后一次随访时完全消失。1 年随访时的中位 VRR 为 100.0%，并持续至最后一次随访。98 名至少随访 1 年的患者中，累积疾病进展率为 3.1%（3/98，[CI：0.6-9.0]）；1 例患者发生淋巴结转移（手术治疗），2 例患者出现新的 PTMC（1 例接受 RFA 治疗，1 例持续 AS）。未观察到重大并发症。心理（基线 vs. 最后一次随访，7.3 vs. 8.0， = 0.002）和社会（8.0 vs. 8.7， = 0.005）生活质量评分在随访期间显著改善，而不影响身体生活质量（8.6 vs. 8.5， = 0.99）。 RFA 可以成为一种合理的策略，可有效且安全地控制肿瘤并改善适合 AS 的低危 PTMC 非老年患者的生活质量。临床试验注册：本试验在 ClinicalTrials.gov 注册：NCT03432299。
