Prospective Randomized Comparative Study of the Effectiveness and Safety of Ultrasound-guided Laser and Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment
研究概览
简要总结
The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.
详细描述
Nodular thyroid disease is a common clinical problem whose prevalence increases with age and with a more widespread use of thyroid ultrasonography. Although most thyroid nodules are benign and need only periodic monitoring, some may require treatment for associated pressure and/or cosmetic symptoms. Although thyroid surgery is the main therapeutic approach for compressive thyroid nodules, it may be associated with several drawbacks. Long-term levothyroxine suppression treatment in elderly patients with large nodular goiters is unsatisfactory because it is ineffective. Furthermore, it is associated with adverse effects on bones and the cardiovascular system. Nonsurgical, minimally invasive treatment modalities such as percutaneous laser ablation (LA) and radiofrequency ablation (RFA) have been used to treat thyroid nodules. However no studies comparing LA and RFA have been published so far.
Aims of the study
- To evaluate whether LA and RFA cause a reduction ≥50% in the volume of thyroid nodules after 6 months and 1 year follow-up
- To evaluate whether the features of thyroid nodules as evaluated by thyroid ultrasound, contrast-enhanced ultrasound, power-doppler and core-biopsy influence LA and RFA outcomes
- To evaluate changes in thyroid function and thyroid autoimmunity after LA and RFA.
- To evaluate differences between LA and RFA in terms of complications, side effects and tolerability.
Patients will be recruited, treated and followed at Santa Maria Goretti Hospital in Latina, Italy, by physicians with expertise in LA and RFA. The scientific coordinator of this study is dr. Silvia Manfrini.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Solitary thyroid nodule or dominating nodule which is well-identifiable in multinodular goiter.
- •Compressive and /or cosmetic symptoms caused by thyroid nodule or increase in nodule volume >20% in 1 year even without symptoms
- •A nodule volume ≥ 5 ml
- •Solid nodule (uniformly compact or nearly completely solid, with a liquid component not exceeding 30%);
- •Two thyroid biopsies resulted negative for malignancy
- •Calcitonin levels within normal ranges
排除标准
- •Hyperfunctioning lesion as evaluated biochemically and/or by 99mTc scintigraphy
- •Pregnancy
研究组 & 干预措施
LA Arm
Percutaneous Laser Ablation
干预措施: Percutaneous Laser Ablation (Device)
RFA Arm
Percutaneous Radiofrequency Ablation
干预措施: Percutaneous Radiofrequency Ablation (Device)
结局指标
主要结局
Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment
时间窗: 12 months
Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months
次要结局
- Variation in TSH levels after treatment(12 months)
- Histopathological features of Thyroid Nodules as Predictive factor of response to treatment(12 months)
- Basal Volume of Thyroid Nodules as Predictive factor of response to treatment(12 months)
- Variation in AbTPO and AbTg levels after treatment(12 months)
- Tolerability evaluated by McGill Pain Questionnaire(0 and 6 months)
- Complications(Up to 1 year follow-up)
- Quality of Life(6 months and 1 year)
研究者
Dr. Silvia Manfrini
Medical Doctor
Campus Bio-Medico University