跳至主要内容
临床试验/NCT04458233
NCT04458233Unknown不适用

FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study

Ziv Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
amount of FNAC non diagnostic Bethesda 1 results

研究概览

简要总结

Ultrasound-guided fine needle aspiration cytology (FNAC) has been proven to be an accurate and efficient tool in thyroid nodule evaluation. Thyroid nodule aspiration is performed by the use of either two techniques; the short axis approach by which only the tip of the needle is observed, or the long axis approach by which the entire needle is observed. Controversial remains of which approach produces better diagnostic adequacy and less non-diagnostic (Bethesda category I) results.

详细描述

200 patients presenting electively for thyroid FNA will recruited. Patients will be randomly assigned to two groups: short axis or long axis FNA. FNA will be performed by a single physician at the Ziv medical center ENT clinics.

patient group randomization will be performed according to a random number sequence generated by the SPSS system. Randomization will be performed on admission prior to the procedure.

FNAC sample diagnosis will be performed according to the regular protocol. Laboratory personnel will be blinded to the sample group.

sample results will be compared and analyzed. A P value of less than 0.05 will be regarded as significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected thyroid nodule requiring diagnostic FNA,

排除标准

  • under or above age limit, no informed consent

结局指标

主要结局

amount of FNAC non diagnostic Bethesda 1 results

时间窗: 1 year

The exact preferred technique for performing Ultrasound Guided FNA is unclear. The correct positioning of the US probe and or the FNA needle could have a marked effect on the diagnostic results of the biopsy

次要结局

未报告次要终点

研究者

发起方
Ziv Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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