A Multicenter, Randomized and Controlled Trial of Radiofrequency Ablation vs. Conventional Surgery as Treatment of Papillary Thyroid Microcarcinoma (PTMC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Recurrent-free Survival Rate
研究概览
简要总结
The treatment of Papillary Thyroid Microcarcinoma (PTMC) nowadays varies among physicians, surgeons and radiologist. The recently published articles show that the prognosis of PTMC by different means of treatment strategies tends to be good. But multicentered, randomized, parallel and prospective study is rare. RFA is the abbreviation of "Radiofrequency Ablation", which tends to be an alternative strategy except conventional surgery. The investigator aims to confirm whether RFA for treating PTMC braces same effectiveness and prognosis comparing with conventional surgery. Besides, this trial also investigates the safety, economy and psychological quality under different treatments.
详细描述
The incidence of thyroid carcinoma, especially the papillary thyroid microcarcinoma (PTMC), has increasingly rapidly, due to the development of technologies of diagnosis, during the past 20 years. PTMC defined by the World Health Organization (WTO) as the largest dimension less than 1 cm. Previous autopsy study demonstrated that the lesions are normal in many people and accompany them latently until they die because of another reasons. The long-term outcome of PTMC is good and, as expected, more than 90% PTMC aren't progress for many years.
Ultrasound-guided Radiofrequency Ablation (RFA) treatment was introduced to clinical practice few years ago. According to the 2015 American Thyroid Association (ATA) guideline, the treatment of radiofrequency and laser ablation are mentioned to be used in recurrent thyroid cancer. But clinical practice shows that the RFA treatment for low risk PTMC braces well effect，low financial budget，high safety and even rare postoperative complication.
Although the cohort study was performed before, the real answer concerning about whether RFA is a rational choice for treating PTMC lacks more powerful evidences. The investigator considers to perform a randomized, controlled and multicenter study as a high-quality evidence and demonstrated the effect of PRF in low risk PTMC treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosis of PTMC (largest dimension<10mm)
- •Age >=18 years old
- •Bethesda Category V or VI
- •Single nodule without thyroid capsule contact
- •Nodule has more than 3mm distance far from recurrent laryngeal nerve, carotid artery and trachea.
- •No clinical evidences show there is local or distant metastasis.
- •Without chemotherapy, radiotherapy and other related therapies.
- •Patients and their family member totally understand and sign the informed consent.
排除标准
- •Multifocal PTMC
- •Combined with other types of thyroid cancer or hyperthyroidism.
- •Contralateral vocal cord paralysis
- •With local or distant metastasis
- •Pregnant woman
- •With radiation exposure history
结局指标
主要结局
Recurrent-free Survival Rate
时间窗: 5 years
record detecting recurrence of PTMC post-surgery or post-FRA
次要结局
- Postoperative Complications(up to 12 months)
- Patient Satisfaction: questionnaire(5 years)
- Anxiety index measured by psychological questionnaire(up to 5 years)
- The Diameter of Lesion(5 years)
- The Volume of Lesion(5 years)
- Serum Concentration of Serological Examination of Thyroid Function(up to 12 months)
- Medical Cost(up to 12 months)
- Hospital Duration(through study completion, an average of 7 days)
- Overall Survival in Patients with PTMC(5 years)
研究者
huang pintong
Director of Department of Ultrasound, Professor of Zhejiang University School of Medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University