Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation
研究概览
简要总结
Percutaneous microwave ablation(MWA) was reported as an effective modality for the management of thyroid nodules(TNs). This study aims to validate MWA as a feasible approach for patients with TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs(one group to treat with MWA and the other group to receive regular ultrasonic follow-up without any treatment) will be evaluated in term of TN volume, ultrasonic image and clinical symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>18 years
- •benign thyroid nodules(TYP 2)
- •solid or predominantly solid(colloid component<30%)large (>3.0ml) thyroid nodules
- •refusal and/or inefficacy of surgery
排除标准
- •pregnancy
- •malignant or suspicious thyroid nodules
研究组 & 干预措施
Group A
MWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation
干预措施: Microwave Ablation (Device)
Group B
untreated no treatment; regular ultrasonic image follow-up
结局指标
主要结局
Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation
时间窗: From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Change of the thyroid nodule volume assessed by using ultrasonography, the volume reduction ratio(VRR) was calculated by the equation: VRR%=\[(initial volume-final volume)\*100\]/initial volume
次要结局
- Improved score on TN-related symptoms(From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months)
- Improved cosmetic grading score(From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months)
研究者
Wenjun Wu
associate chief physician
First Affiliated Hospital of Wenzhou Medical University