NCT04879355Unknown不适用
The Use of Spinal Needles for Ultrasound-guided Fine Needle Aspiration From Thyroid Nodules - a Protocol for a Multicentre Randomised Controlled Trial
Preben Homøe2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2021年11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
- 350
- 试验地点
- 2
- 主要终点
- Diagnostic rate
研究概览
简要总结
This is a multicentre, two-arm, randomised and controlled trial. Adults with thyroid nodules suspected of malignancy are to be included consecutively. A total of 350 patients are randomly assigned 1:1 to have FNA with a spinal (25G) or a conventional (25G) needle. The primary outcome is the rate of diagnostic cytological samples according to the Bethesda system. Secondary outcomes are diagnostic accuracy, patient's experienced pain and complication rates.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The patients and the pathologists are blinded to the intervention, while the clinicians performing the FNAs are not.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age.
- •Patients referred for evaluation of a cold nodule on thyroid scintigraphy and with EU-TIRADS score of 3 or higher.
- •Score 3 and > 20 mm in size.
- •Score 4 and >15 mm in size.
- •Score 5 and >10 mm in size.
- •Clinical suspicion of thyroid cancer:
- •PET-positive thyroid tumor.
- •Thyroid tumor and palsy of the recurrent laryngeal nerve.
- •Rapidly growing thyroid tumor.
- •Hard and/or immobile thyroid tumor.
- •Tumor in the thyroid with suspicious lymph nodes.
排除标准
- •Previous participation in the study.
- •Language or other barriers not allowing adequate information.
结局指标
主要结局
Diagnostic rate
时间窗: 1 year
The percentage of samples evaluated as "diagnostic" by the pathologist.
次要结局
- Complication rate(Till 1 month after last inclusion. Corresponding to about 1 year)
- Diagnostic accuracy(About 2 years)
- Pain assessment(About 2 years)
研究者
Preben Homøe
Professor
Zealand University Hospital
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Diagnostic Significance of CTCs in Patients With Thyroid Nodules (Circulating Tumor Cells)Diagnoses DiseaseThyroid NoduleNCT03772496Cancer Institute and Hospital, Chinese Academy of Medical Sciences200
终止
不适用
Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve BlocksIn-plane Ultrasound-guided Regional Anesthesia PerformanceNCT01690156University of New Mexico62
Unknown
不适用
Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid CancerElastographyThyroid NoduleNCT02462512Dong Jun Lim590
已完成
不适用
Ultrasound-guided Thyroid Cartilage Plane Block for Awake IntubationSuperior Laryngeal Nerve BlockNCT06065475Nanjing First Hospital, Nanjing Medical University60
已完成
不适用
Ultrasound Guided Cannulation of Dialysis FistulasHaemodialysisNCT01163981University of Hull31