Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- diagnostic performance of imaging
研究概览
简要总结
The study aims are:
- To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism.
- To compare 4D-CT, scintigraphy, and ultrasound for the ability to perform focused parathyroidectomy, and for rates of persistent hyperparathyroidism and complications from parathyroid surgery.
Methods The investigators will create a multicenter registry consisting of patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016. Initial participating centers include Duke University Medical Center, University California Los Angeles (UCLA) and University of Arkansas for Medical Sciences (UAMS).
There will be no intervention in the patient's treatment or imaging. The management will be determined by the surgeon or clinician supervising the patient's care.
The registry will consist of patient data regarding basic demographics, history of prior neck/chest surgery or radiation, parathyroid imaging, biochemical evaluation, intraoperative surgical findings, parathyroid pathology, and surgical outcomes within the first 6 months (persistent disease, recurrent laryngeal nerve injury, and hypoparathyroidism). Data will be entered into REDCap with no PHI. The investigators expect to include 3000 patients in the registry (1000 from Duke).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients having parathyroid surgery for primary hyperparathyroidism from July 2009 to June 2016
排除标准
- •age less than 18 years
- •parathyroid carcinoma
- •secondary or tertiary hyperparathyroidism
结局指标
主要结局
diagnostic performance of imaging
时间窗: 6 months
次要结局
- parathyroidectomy surgical complications(6 months)
- ability to perform focused parathyroidectomy(6 months)
- rates of persistent hyperparathyroidism after parathyroidectomy(6 months)
