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临床试验/NCT04879173
NCT04879173Unknown不适用

The Clinical Value of Microvascular Ultrasonography in Real-time Differential Diagnosis of Thyrotoxic Patients Between Hyperthyroidism and Thyroiditis

Dong Jun Lim1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
The optimal value of vascular index for differentiating the thyrotoxicosis reason

研究概览

简要总结

This study aims to verify the clinical value of thyroid ultrasound with microvascular flow imaging in thyrotoxic patients for differential diagnosis between hyperthyroidism and thyroiditis. We intend to use the RS85 Ultrasound device manufactured by Samsung Medison. Graves' disease and painless thyroiditis/subacute thyroiditis are the main cause of thyrotoxicosis.

Precise discrimination between Graves' disease and painless thyroiditis/subacute thyroiditis is clinically very important in determining treatment methods, such as the prescription of antithyroid drugs. Primary endpoint was to verify the value of vascularity index, defined by Blood pixel in range of image / Total pixel in range of image .Seondary endpoint was to verify the superiority value of Microvascular flow imaging to discriminate thyrotoxicosis patients compared with Color doppler/ Power doppler ultrasound imaging and conventional ultrasound imaging.

详细描述

Thyrotoxicosis refers to the appearance of various clinical symptoms or signs due to and excessive increase of thyroid hormone in the body. Graves' disease, which causes thyrotoxicosis, is one of the most common autoimmune diseases and is known to account for 0.5% of the population. Precise discrimination between Graves' disease and painless thyroiditis/subacute thyroiditis is clinically very important in determining treatment methods.

The Microvascular flow imaging technology is expected to show higher sensitivity and accuracy than conventional color Doppler images in differentiating patients between Graves' disease and painless thyroiditis/subacute thyroiditis. We enrolled thyrotoxicosis patients in their initial presentation and used RS85 Ultrasound device manufactured by Samsung Medison to discriminate Graves' disease and painless thyroiditis/subacute thyroiditis. Power / Color doppler ultrasound imaging and conventional ultrasound imaging were used. Tranverse and longitudinal plane of the dominant lobe were selected for imaging. Doppler Adler's method was used to asscess vascularization. To assess the vascularity index, which is defined by Blood pixel in range of image / Total pixel in range of image, we selected the total tranverse plane of the thyroid as range of image.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Initial presentation with thyrotoxicosis

排除标准

  • Past history of thyroidectomy
  • Factitious thyrotoxicosis
  • Unable for ultrasound

结局指标

主要结局

The optimal value of vascular index for differentiating the thyrotoxicosis reason

时间窗: 12 months

次要结局

  • The superiority value of Microvascular flow imaging(12 months)

研究者

发起方
Dong Jun Lim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dong Jun Lim

professor

Seoul St. Mary's Hospital

研究点 (1)

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