A Multicenter Prospective Controlled Trial of Laser Ablation Versus Surgery for the Treatment of Papillary Thyroid Microcarcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 13
- 主要终点
- Serological examination of thyroid function
研究概览
简要总结
This is a multicenter prospective controlled trial of percutaneous laser ablation(PLA) versus conventional surgery for the treatment of papillary thyroid microcarcinoma (PTMC).
详细描述
PLA is the acronym for "Percutaneous Laser Ablation". The treatment consists in the destruction (ablation) of Papillary Thyroid Micro Carcinoma by means of optical fibers that deliver high-energy light (laser) into the lesion through skin puncturing (percutaneous). The procedure is performed under ultrasound imaging guidance (ultrasound-guided). The destruction of the lesion occurs through overheating and coagulation. PLA, however, still needs a large-scale validation trial in order to be considered as an effective alternative to both surgery or follow-up for low-risk PTMC in elderly patients and/or in patients with co-morbidities that might expose the patients to a high surgical risk.
After a comprehensive information, patients will be consecutively assigned to Group 1 (surgery, preferentially lobectomy) or to Group 2 (percutaneous laser ablation, performed according to the attached procedure).Peri and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered.
The aims of this study are as follows: 1.To establish the rate of cure or partial ablation; 2.To compare the complication rate, time expenditure and costs of two procedures; 3.To assess changes in thyroid function and the need of substitution therapy with two procedures; 4.To assess the tolerability of the procedure, the customer satisfaction and the impact on the quality of life of the patients between conventional surgery and PLA.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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 diagnosed PTMC (maximun diameter> = 5 mm and < = 10 mm) proved by fine needle aspiration biopsy with good thyroid function;
- •Age≥ 18 Y;
- •Single nodule without thyroid capsule contact;
- •There had more than 3mm distance between nodules and trachea, carotid artery, recurrent laryngeal nerve (The distance should up to 5mm after injection of isolation fluid);
- •No coarse calcification or eggshell-like calcification;
- •Imaging examination without local or distant metastasis;
- •Without chemotherapy, radiotherapy and other related therapies;
- •A complete clinical, pathological and follow-up information;
- •Get informed consent signed by the patient or family member.
排除标准
- •Multifocal PTMC;
- •Combined with other types of thyroid cancer or hyperthyroidism;
- •Lesion contact with thyroid capsule or located in the isthmus;
- •Serious coagulation dysfunction;
- •Contralateral vocal cord paralysis;
- •Imaging examination with local or distant metastasis;
- •Active Tuberculosis and HIV-positive patients;
- •Patients can not understand or follow research protocol;
- •Pregnant woman.
结局指标
主要结局
Serological examination of thyroid function
时间窗: up to 12 months
Hyperthyreosis or hypothyroidism.
次要结局
- Recurrence rate(up to 12 months)
- Therapeutic Effect(up to 24 months)
研究者
WeiWei Zhan
Director, Head of Ultrasound Department; Clinical Professor
Ruijin Hospital