Comparing the Efficacy and Safety of Radiofrequency Ablation Versus Microwave Ablation for the Treatment of Large Benign Thyroid Nodules, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Volume reduction rate (VRR) of thyroid nodule at 6 months (%)
研究概览
简要总结
We conduct a multi-institutional randomized control trial of RFA and MWA for the primary treatment of large, benign nodules. Adult patients >/=18 years of age who have a solitary thyroid nodule ≥20ml in volume who presents to 1) Columbia University, NY or 2) Queen Mary Hospital, Hong Kong for consultation will be eligible for enrollment in the study. They will need either a) two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or b) one benign fine needle biopsy and low suspicion characteristics on ultrasound. Both functional and non-functional nodules are eligible.
Patients will be randomly assigned to either treatment arm a) RFA or treatment arm b) MWA according to a pre-generated block randomization list.
详细描述
Benign thyroid nodules can cause compressive symptoms for patients, including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. Some nodules will become autonomously functioning causing hyperthyroidism. Traditionally the gold standard treatment for these benign, but problematic nodules, has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation.
Introduced in the early 2000s, ultrasound-guided percutaneous ablation of thyroid lesions has emerged as a potential alternative to surgery in patients with benign thyroid nodules. Of the myriad ablation methods, the most commonly used technique are radiofrequency ablation (RFA) and microwave ablation (MWA). The two techniques used different mechanisms for heat generation.
Current evidence comparing RFA versus MWA for thyroid ablation were limited and were either retrospective or non-randomized, with focus mainly on small thyroid nodules of ≤10ml in volume. There is a lack of high quality evidence on the safety and efficacy of RFA versus MWA for the treatment of large thyroid nodules (≥20ml).
The aim of this randomized controlled trial is to compare the safety and efficacy of RFA and MWA in the treatment of large, benign thyroid nodules.
The primary outcome of is the volume reduction rate at 6 months after ablation. The secondary outcomes include safety, complication rates and quality of life after both procedures.
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
- •who have a solitary thyroid nodule ≥20ml in volume
- •two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound
- •Both functional and non-functional nodules are eligible
排除标准
- •have multiple nodules and planned simultaneous ablation
- •cytologically indeterminate thyroid nodules
- •nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound
- •current pregnancy or cardiac arrhythmias
研究组 & 干预措施
Microwave ablation
Apply microwave ablation to those large benign thyroid nodules for shrinkage purpose
干预措施: Microwave ablation (Device)
Radiofrequency ablation
Apply radiofrequency ablation to those large benign thyroid nodules for shrinkage purpose
干预措施: Radiofrequency ablation alone (Device)
结局指标
主要结局
Volume reduction rate (VRR) of thyroid nodule at 6 months (%)
时间窗: 6 months
To measure the volume reduction rate (VRR) of thyroid nodule at 6-month. volume of nodule= length(cm) x width(cm) x depth(cm) x (π / 6 ) VRR = \[(volume at baseline - volume at 6-month)/volume of baseline\] x 100%
次要结局
- Changes in compressive symptom scores (0-100)(12 months)
- Changes in cosmetic symptom scores (1-4)(12 months)
- Peri-operative pain scores (0-10)(12 months)
- Volume reduction rate (VRR) of thyroid nodule at 12 months (%)(12-months)
- Complications from procedure including vocal cord palsy, bleeding, infection, nodule rupture, skin burn(12 months)
研究者
Man Him Matrix Fung
Clinical Assistant Professor
The University of Hong Kong