Ultrasound-guided Radiofrequency Ablation Versus Radioactive Iodine as Treatment for Hyperthyroidism Caused by Solitary Autonomous Thyroid Nodules
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 14
- 主要终点
- Hypothyroidism
研究概览
简要总结
The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.
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
- •Age > 18 years
- •Hyperthyroidism or subclinical hyperthyroidism caused by a solitary hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid gland, or in a multinodular goitre (MNG), with a diagnosis based on the following characteristics:
- •Blood TSH level below the lower limit of normal, and associated with either normal or elevated FT4 and FT3 levels
- •Anti-TSH antibody negative
- •Solitary HTN confirmed by a diagnostic I-123 scintigraphy, corresponding with a well demarcated thyroid node on ultrasound, cystic degeneration < 75%, nodule size <50 mm.
- •Treatment with RAI indicated, and eligible for RFA treatment
- •Signed informed consent Patients who are ineligible for randomization due to unsuitability for RFA, may be eligible for the RAI cohort group.
排除标准
- •Multifocal HTN
- •HTN > 50 mm
- •Presence of a medical device susceptible to disturbances caused by RFA generated currents
- •Patients with physical or behavioural disorders that preclude safe isolation in radiation protection rooms, or safe RFA procedure under local anesthesia
- •Patients with dysphagia, oesophageal stenosis, active gastritis, gastric erosion, a peptic ulcer or impaired gastro-intestinal motility
- •Uncorrectable haemorrhagic diathesis
- •Pregnant or breastfeeding women
研究组 & 干预措施
Radiofrequency ablation
Patients allocated to the radiofrequency ablation (RFA) arm will undergo RFA under local anaesthesia with the moving-shot technique.
干预措施: Radiofrequency ablation (Device)
Radioactive iodine, study protocol
Patients allocated to this arm will undergo treatment with radioactive iodine (I-131) according to a standardized dose-calculation.
干预措施: Radioactive iodine (Drug)
Radioactive iodine, cohort
This group contains patients who are not randomized and have given informed consent undergo treatment with radioactive iodine (I-131) according to local standard (e.g. fixed dose or dose-calculation based on iodine uptake and thyroid nodule mass).
干预措施: Radioactive iodine (Drug)
结局指标
主要结局
Hypothyroidism
时间窗: 1 year post-intervention
Incidence of hypothyroidism (defined as TSH above normal values with/without decreased FT4 and/or FT3 levels)
次要结局
- Cure rate(1 year post-intervention)
- Treatment related adverse events(6 weeks and 3, 6 and 12 months post-intervention)
- Course of thyroid function(Baseline, 1 and 6 weeks, 3, 6, 9 and 12 months post-intervention with an extension of follow-up up to 5 years.)
- Short-term patient satisfaction(1 week and 1 year post-intervention)
- Thyroid nodule volume(Baseline, 6 and 12 months post-intervention)
- Thyroid related quality of life(Baseline, 6 and 12 months after intervention)
- Cost-effectiveness(Baseline, 6 weeks, and 3, 6, 9 and 12 months post-intervention)