Radiofrequency ablation of Low Risk Papillary Thyroid Microcarcinoma using Medical Electrocautery Apparatus : Single Center, Open, Single-Arm, Investigator Initiated Trial for Exploratory Evaluation of Safety and Efficacy
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
Importance: 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 non-elderly patients eligible for AS. Objective: To evaluate the efficacy and safety of ultrasound (US)-guided radiofrequency ablation (RFA) for tumor control and quality of life (QoL) management in non-elderly patients with PTMC eligible for AS. Design, setting, and patients: This prospective, non-randomized controlled trial was conducted at a single tertiary referral hospital from 2018 to 2021. Of 559 non-elderly (=60 years) adult patients with PTMC eligible for AS, 227 chose AS and 100 patients underwent RFA for their management. Intervention: US-guided RFA Main outcomes and Measure: The primary endpoints were the disease progression rate, QoL scores, and complication rates. The secondary endpoints were technical success and volume reduction rate (VRR). Results: The median age of the study population was 42 years (range, 27–59 years), and 83% were female. The median follow-up was 30 months (range, 12–56 months). All 100 patients underwent RFA with technical success. The cumulative disease progression rate among 98 patients who underwent at least 1-year follow-up was 3.1%; one patient had lymph node metastasis (treated with surgery), and two patients had new PTMC (1 treated with RFA, 1 ongoing AS). Psychological (baseline vs. last follow-up, 7.3 vs. 8.0, P=.002) and social (8.0 vs. 8.7, P=.005) QoL scores significantly improved during follow-up without compromising physical QoL (8.6 vs. 8.5, P=0.99). Most of the ablation zones showed continuous volume reduction, and 95.9% (94/98) 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. Major complications were not observed. Conclusion and Relevance: The results of this non-randomized clinical trial suggest that RFA can be a reasonable strategy for effectively and safely controlling tumors and improving QoL in non-elderly patients with low-risk PTMC eligible for AS.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •Among patients who chose to undergo active surveillance instead of immediate surgery, those who provide valid informed consent to radiofrequency ablation (RFA) prior to the study procedure
- •-Patients with the final diagnosis of papillary thyroid cancer [PTC] (Bethesda category VI) or suspicious for PTC (Bethesda category V) who meet the following inclusion criteria
- •- Age 19-60 inclusive
- •- Nodules with the largest diameter equal to or less than 1.0 cm
- •- No evidence of pathologically confirmed or clinically suspected lymph node or distant metastasis
- •- PTC subtypes other than those with poor prognosis (tall cell, diffuse sclerosing, columnar cell, solid variant)
- •- No radiologic evidence of direct invasion to adjacent organs including the trachea, esophagus, perithyroidal nerves, vessels, or muscles
- •- Nodules for which complete ablation is deemed to be technically feasible on US evaluation
- •- Patients who give informed consent to undergo RFA instead of active surveillance or immediate surgery and serial follow-up US examination on a regular basis
- •- No bleeding tendency on blood tests (complete blood count [CBC], prothrombin time [PT], activated Partial Thromboplastin Time [aPTT])
排除标准
- •- who cannot be routinely followed up according to the study schedule
- •- the nodules with Bethesda category I, II, III, or IV by fine-needle aspiration or needle biopsy.
- •- Age under 19 or above 60 yrs
- •- who has hyperthyroidism that requires treatment
- •- multifocal papillary thyroid microcarcinoma
- •- who is pregnant or on breast-feeding
- •- who has pacemaker