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临床试验/NCT02381925
NCT02381925撤回不适用

Multicenter Registry Comparing Preoperative Imaging for Primary Hyperparathyroidism

Duke University0 个研究点开始时间: 2015年3月6日最近更新:
适应症

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:

  1. To compare the diagnostic performance of parathyroid four-dimensional CT (4D-CT), scintigraphy, and ultrasound in patients who underwent parathyroid surgery for primary hyperparathyroidism.
  2. 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

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)

研究者

申办方类型
Other
责任方
Sponsor

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