Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline in TN volume
研究概览
简要总结
Percutaneous radiofrequency thermal ablation (RTA) was reported as an effective tool for the management of thyroid nodules (TNs). This study aims to validate RTA as a valid approach for patients with compressive TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs (one group to treat with RTA and a matched untreated control group) will be evaluated in term of TN volume, thyroid hormones and clinical symptoms.
详细描述
Thyroid nodules (TNs) are very common in the general population, with a prevalence of about 50% in subjects older than 60 years undergoing neck ultrasound examination.
The great majority of TNs are benign, but they can be responsible for pressure symptoms in the neck and result in discomfort and decreased quality of life. Large compressive TNs may result in life-threatening conditions because of the potential acute onset of respiratory crisis. Percutaneous radiofrequency thermal ablation (RTA) is a minimally invasive procedure which has been firstly develop to treat patients with liver cancer and has been then used to treat both malignant and benign tumor nodules in many organs. RTA also represents a promising new approach for the management of TNs.The current prospective comparative study investigated the long-term effectiveness of RTA in patients with both toxic and non-toxic compressive TNs.
Forty consecutive patients with TNs with pressure symptoms were prospectively enrolled in this study. Patients were randomised as follows: 20 patients were treated with a single RTA session (group A) and 20 patients did not receive any treatment and were only followed-up (group B).
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 87 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 (TYR 2)
- •solid or predominantly solid (colloid component < 30%) large (> 4.0 mL) thyroid nodules
- •refusal and/or inefficacy of surgery and/or radioiodine therapy.
排除标准
- •pregnancy
- •malignant or suspicious thyroid nodules.
结局指标
主要结局
Change from baseline in TN volume
时间窗: 12 months
Evaluation of TN volume by using Ultrasonography.
次要结局
- Safety(At 1, 3, 6, 12 months after baseline.)
- Change from baseline in TN volume(6 months)
- Efficacy on TN-related neck symptoms(From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.)
- Efficacy on TN hyperfunction(Efficacy on TN-related neck symptoms Time Frame: (FDAAA) From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months.)
研究者
Annamaria Colao
Department of Clinical and Molecular Endocrinology and Oncology
Federico II University