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临床试验/NCT03434067
NCT03434067Unknown不适用

The Application of Rapid PTH Test Paper in Operation of Hyperparathyroidism

Bo Wang,MD1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
Serum PTH

研究概览

简要总结

The half-life of the parathyroid hormone is about 4min, blood pth test is use in operation to confirm that parathyroid tumor is removed. but the blood pth test is time consuming and unpractical in most of hospital. this study will compare the application of rapid PTH test paper in operation of hyperparathyroidism.PTH test were measured in operation in different way. it will test at the time of preoperation, 15 minutes after surgery, 1 hour after surgery and 24 hours after surgery. thus evaluate the reliability and accuracy of PTH test paper in evaluating the Miami principles with the linear relation of blood PTH and the PTH test paper method.

详细描述

Primary hyperparathyroidism is a clinically common disease. At present, the gold standard for determining whether the operation is successful is based on the Miami principle. That means The PTH hormone decreased to 30% of the baseline level after 15min after the tumor was removed. However, due to the differences in PTH monitoring conditions in various hospitals, many hospitals cannot perform rapid PTH monitoring in the operation. Therefore many doctors choose rapid freezing pathology to confirm the lesion., This also led to the inability to evaluate PTH in the presence of multiple lesions,and resulting in the need for reoperations.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary hyperthyroidism.
  • Secondary hyperthyroidism
  • Unilateral thyroidectomy.
  • Total thyroidectomy and bilateral central compartment dissection

排除标准

  • age Older than 70 or younger than 18.

结局指标

主要结局

Serum PTH

时间窗: 0 minutes, 15 minutes, 1 hour and 24 hours post operation

Routine serum PTH test, using immunoluminescence.

PTH test paper

时间窗: 0 minutes, 15 minutes, 1 hour and 24 hours post operation

PTH test paper test for blood

Serum calcium

时间窗: 0 minutes, 15 minutes, 1 hour and 24 hours post operation

Routine serum electrolyte detection.

次要结局

未报告次要终点

研究者

发起方
Bo Wang,MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bo Wang,MD

Clinical professor

Fujian Medical University

研究点 (1)

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