跳至主要内容
临床试验/NCT03605472
NCT03605472Unknown不适用

Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism

CHU de Reims1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
CHU de Reims
入组人数
100
试验地点
1
主要终点
Adenoma parathyroid diagnosed using cervical ultrasound

研究概览

简要总结

The biological diagnosis of the primary hyperparathyroidism is now facilitated by the reliability of the balance of phosphate and calcium and the dosage of parathyroid hormone (PTH).

This diagnosis of preoperative localization is important as surgery are now targeted to the responsible lesion.

The "gold standard" for this localization is the cervical ultrasound exploring the usual sites of adenomas and a MIBI scintigraphy (the parathyroid adenoma significantly concentrating this cell marker).

However, the diagnosis of preoperative localization remains a subject of discussion as to the most appropriate tests. Indeed, the morphological diagnosis is performed at the ultrasound stage in more than half the cases. It is the new performance of this morphological examination that makes it possible to obtain these results.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary hyperparathyroidism with surgery indication
  • Age > 18yo

排除标准

  • surgical contraindication
  • medical treatment by cinacalcet
  • non sporadic hyperparathyroidism
  • Age <18yo
  • Protected by the law

研究组 & 干预措施

Patients

Experimental

干预措施: cervical ultrasound (Other)

结局指标

主要结局

Adenoma parathyroid diagnosed using cervical ultrasound

时间窗: Day 0

Adenoma parathyroid diagnosed using cervical ultrasound. Cervical ultrasound will be realized by a endocrinologist trained in the cervical ultrasound and not informed of the results of the echoscintigraphy

Adenoma parathyroid diagnosed using echoscintigraphy

时间窗: Day 0

Adenoma parathyroid diagnosed using echoscintigraphy. Echoscintigraphy will be realized by a nuclear physician not informed of the results of the cervical ultrasound

Adenoma parathyroid diagnosed using anatomopathology

时间窗: Day 0

Adenoma parathyroid diagnosed by anatomopathologist, after surgery.

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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