Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.
试验速览
- 阶段
- 不适用
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Thyroid volume
研究概览
简要总结
The purpose of this clinical trial is to investigate the accuracy of applying three-dimensional ultrasound on thyroid gland patients when determining a gland volume.
The method will be compared to conventional b-mode ultrasound where three axis measurements (length, width, and depth) are evaluated in the ellipsoid model.
The three dimensional (3D) method is utilizing optical tracking connected to the ultrasound image to form cross-sectional imaging. Patients enrolled in the study are set for complete thyroidectomies enabling a true volume of the gland by water displacement after excision.
The aim is to find if this 3D method is more accurate in volume estimation than the ellipsoid model.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients referred to Rigshospitalet to undergo a complete thyroidectomy including patients with previous hemithyroidectomy
- •Adults, 18 or older.
- •Ability to give written informed consent
排除标准
- •Thyroid glands that are too enlarged causing visualization/measurement impairment with ultrasonography.
- •Thyroid cancer with preoperative suspected extracapsular spread.
- •Thyroids or lymph nodes that need frozen section examination.
结局指标
主要结局
Thyroid volume
时间窗: 1 hour
Obtaining thyroid volume with 2D ultrasound (length x Width x depth\*(Pi/6)) and 3D ultrasound with optical tracking and comparing the respective methods with a reference volume. Water displacement being gold standard for reference volume.
次要结局
- Shrinkage in gland after excision(30 minutes)
- Interobserver variability(2 hours)
研究者
Klara Bay Rask
Stud.Med.
Rigshospitalet, Denmark