跳至主要内容
临床试验/NCT01750593
NCT01750593Unknown不适用

Efficacy of Radiofrequency Ablation in Thyroid Nodules

Bezmialem Vakif University5 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2013年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
5
主要终点
Shrinkage of the thyroid nodule after radiofrequency ablation

研究概览

简要总结

Thyroid nodules are common problems and although > 95% are stated to be benign, they may cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with their function, size and localization. Especially for these nodules, patients undergo surgery and face up with the problems associated with surgical complications although they are not cancer. In some studies, radiofrequency ablation previously used for intrabdominal tumors like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid nodules and in some recurrent thyroid cancer cases. Therefore, the investigators decided to use this method in our patients having nodules like previously mentioned and see the efficacy and safety of the technique.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems;
  • a poor surgical candidate or refusal to undergo surgery;
  • fine-needle aspiration cytology and US findings that were compatible with a benign nodule;
  • anxiety about a malignancy.

排除标准

  • a nodule less than 5 mm in size;
  • follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC);
  • a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result;
  • previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.

研究组 & 干预措施

radiofrequency ablation of thyroid nodule

Experimental

Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation

干预措施: Radiofrequency ablation of the thyroid nodule (Procedure)

结局指标

主要结局

Shrinkage of the thyroid nodule after radiofrequency ablation

时间窗: 6 months

次要结局

  • Disappearance of the nodules in follow up(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeliz Emine Ersoy

M.D.

Bezmialem Vakif University

研究点 (5)

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