Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma: Safety and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change of tumor size
研究概览
简要总结
This is a single center prospective clinical trial with regard to efficacy and safety of radiofrequency ablation of papillary thyroid microcarcinoma.
详细描述
For treatment of papillary thyroid microcarcinoma (PTMC), radiofrequency ablation (RFA) will be performed with the supine position and neck extended under ultrasonogrphic guidance. Before RFA, local anesthesia will be performed. RFA system including radiofrequency generator (VIVA RF system, STARmed, Goyang-si, Korea) and internally cooled electrode (star RF electrode, STARmed, Goyang-si, Korea) will be used. With regard to RFA procedure, moving shot technique and hydrodissection, if indicated, will be used. After RFA, follow-up will be performed using ultrasonography, serum thyroid function test, and questionnaire for quality of life by face-to-face interview at 2 months, 6, 12, 18, 24 months during the first 2 years after RFA, and yearly afterwards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who agrees to the consent form
- •aged from 19 to 60 years old
- •who has been diagnosed with Bethesda category V or VI by fine needle aspiration or needle biopsy
- •whose thyroid cancer is 1 cm or smaller than 1 cm length
- •who does not have lymph node or distant metastasis
- •whose thyroid cancer does not have extrathyroidal extension
- •in whom it seems technically possible to completely ablate thyroid cancer using RF
排除标准
- •who cannot routinely followed up according to the study schedule
- •who has been with Bethesda category I, II, III, or IV by fine needle aspiration or needle biopsy.
- •who has hyperthyroidism that requires treatment
- •who has bleeding tendency
- •multifocal papillary thyroid microcarcinoma
- •who is pregnant
结局指标
主要结局
Change of tumor size
时间窗: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Maximal dimension (mm) of ablation zone on Ultrasonography
次要结局
- Development of Metastasis(baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years)
- Change of Quality of Life(baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years)
- Incidence of potential side effects from RFA(baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years)
研究者
Ji-hoon Kim
professor
Seoul National University Hospital