Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules by Percutaneous Radiological Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Procedure response rate
研究概览
简要总结
The purpose of the present protocol is to evaluate the response rate to treatment of these symptomatic benign nodules with radiofrequency as an alternative to surgical treatment.
This thyroid nodules ablation with radiofrequency will be directed by a single percutaneous procedure guided by ultrasound. The procedure includes an ultrasound with percutaneously radiofrequency ablation of benign thyroid nodule. Clinical and ultrasonographic monitoring will last a year with consultations at 2 weeks (consultation only), 3 months, 6 months and 1 year (consultation, ultrasound TSH). The success of this procedure will be controlled with 3 successive ultrasounds the following year. The expected results are a decrease in the size of the nodule by at least 50% and a reduction in the functional and aesthetic discomfort, with less frequent complication than what is expected with surgery. The present study also intends to determine the medico economic impact of this technique compared to surgery.
详细描述
Thyroid benign nodules represent a major public health problem because they are very common (subclinical nodules were found in half of woman beyond 60 years). The main risk factors include age, female gender, parity, smoking and family history of thyroid nodules or thyroiditis. The assessment is based on biology, ultrasound and fine needle aspiration and intends to determine the benign nature (95%) or cancer (5%) of the nodules and if they are functional or not (toxic nodule). Most benign nodules are asymptomatic but some of them because of their size and location can cause a functional disorder (compression or swallowing disorder) or aesthetic and psychological resounding.In current practice, these nodules are sometimes treated with surgery that impact on patient quality of life (need to take L-Thyroxine, difficulties related to the possible occurrence of complications like hypoparathyroidism or laryngeal paralysis) and socio-economic constraints especially when complications occur. To limit the number of unnecessary and potentially risky surgeries, patients should therefore be well selected. If surgery is the preferred treatment of thyroid cancer, alternative techniques like radiofrequency seem interesting for benign nodules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Euthyroid or hypothyroidism properly substituted with normal TSH
- •Benin nodule proved by FNA (Bethesda) and normal Calcitonin
- •Nodule size> 1cm and / or increase in size
- •Single nodule or asymptomatic nodules associated
- •Symptomatic nodule with functional impairment and / or aesthetic Patient Agreement
- •Patient with insurance coverage
- •Written agreement for participation
排除标准
- •The exclusion criteria are related to the histological nature of the nodule and the necessary of the procedure:
- •Allergy to local anesthetics
- •FNA non-contributory or suspicious nodule (Bethesda)
- •Multiple nodules more than 2cm
- •Hyperthyroidism or hyperparathyroidism associated requiring surgical intervention.
- •Taking a treatment with anticoagulant or double antiplatelet
- •Patient with a Pacemaker
- •Contralateral laryngeal paralysis in nodule
- •Purely cystic nodule
- •Nodule in contact with the recurrent nerve
- •Patient Refusal
- •Pregnant and breastfeeding women
- •Patient trust, guardianship or safeguard justice.
结局指标
主要结局
Procedure response rate
时间窗: 6 months
First estimate of the procedure response rate (patient with complete procedure in percentage)
次要结局
- Change in nodular volume(at 6 and 12 months)
- volume change of nodules by at least 50 percent, at 6 months(at 6 months)
- volume change of nodules by at least 50 percent, at 12 months(at 12 months)
- complete disappearance of symptoms(at 12 months)
- aesthetic change(at 3, 6 and 12 months)
- one or more complications(at 6 and 12 months)
- Assessment of pain during the procedure with visual analogue scale(between Day 1 and Day 15)
- patients requiring L-thyroxine replacement therapy(at 6 and 12 months)
- Economic evaluation from the point of view of the hospital(Between Day 1 and 12 months)
- patients who have used analgesics(between Day 1 and Day 15)
- Economic evaluation from the point of view of the health insurance(Between Day 1 and 12 months)