Utility of a Second Ultrasound-guided Fine Needle Aspiration for the Detection of Thyroid Cancer in the Management of Single Thyroid Nodules or Multinodular Goitre.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Status nodule
研究概览
简要总结
Thyroid nodules are common (prevalence of 12.7% in women), but are malignant in only 5% of cases. International experts agree that a preliminary cytological examination by fine needle aspiration (FNA) is required. The management of patients with cytological results consistent with malignant or suspicious for malignancy nodules is well codified and generally involves surgery. However, there is no consensus concerning 1) the utility of a second FNA during the monitoring of benign nodules. Certain studies have recommended a second FNA, whereas others have recommended ultrasound monitoring alone; 2) the contribution of ultrasound criteria to the decision as to whether to carry out a second FNA, particularly if the nodule increases in size; 3) the management of nodules classified as doubtful or suspect on needle biopsy, many of which prove to be benign (20 to 30% are malignant), raising questions about the utility of systematic thyroid surgery or the justification for a second FNA; 4) the management of patients with non significant (NS) findings on FNA, for whom immediate surgery, monitoring or a second FNA may be recommended and 5) the procedure to be followed for nodules present in patients with multinodular thyroid disease.
详细描述
Background :
A few studies have tried to evaluate the value of a second needle biopsy. Ultrasound criteria for malignancy have been described but are mostly unvalidated. Only a very small number of immunocytochemical studies using several antibodies have been reported, mostly dealing with series of less than 50 cases. The Bethesda State of Science Conference held in October 2007 (ahead on print, 2009) on fine-needle biopsy of the thyroid considered that no sufficiently robust studies of this technique had yet been carried out and that prospective studies were required.
Objectives:
The principal objective of this study is to determine the utility of a second needle biopsy in the routine management of patients presenting, for a given nodule, initial cytological results that were non-significant, benign, doubtful or suspect. The secondary objectives are to determine the utility of various pre-determined ultrasound criteria and of the collection of cells in liquid medium combined with immunocytochemistry.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patient are more than 18 years old
- •Patient with a unique or several thyroid solid nodules more than 10 mm wide
- •Patient who accept to be followed over 18 months
- •Study Informed patient, non opposed to his/her own data analyzes
排除标准
- •Pregnant women
- •Patient with previous data of thyroid cancer
- •Patient with low TSH (inferior to local norm)
- •Patient refusing thyroid surgery policy/ rule
- •Irresponsible patient or patient refusing to participate
- •Patient with clinical or psychological state not permitting study sample
研究组 & 干预措施
Fine needle aspiration
Patient with solid nodules more than 10 mm in diameter will be biopsied by ultrasound-guided fine-needle aspiration(FNA)after consultation with an endocrinologist or ENT specialist.
干预措施: Fine needle aspiration (Procedure)
结局指标
主要结局
Status nodule
时间窗: Inclusion, 6, 12 and 18 months
次要结局
未报告次要终点