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临床试验/NCT02906748
NCT02906748Unknown不适用

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
280
试验地点
1
主要终点
parahthyroid hormone gradient by comparing between grafted and non-grafted forearm

研究概览

简要总结

The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH) into the circulatory system of the body through the capillaries. But when parathyroid glands were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH to examine whether the graft functions. So the investigators took the forearm as the aim place for auto-transplantation, either subcutaneous or brachioradialis, with its relatively fixed - antecubital vein blood test which is simple. The survival criteria is assumed as the PTH gradient of 1.5 times or greater through comparing the bilateral PTH value in grafted and not-grafted forearm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with indications for PA treatment during cervical surgery

排除标准

  • patients suffering secondary hypoparathyroidism with forearm fistulization

结局指标

主要结局

parahthyroid hormone gradient by comparing between grafted and non-grafted forearm

时间窗: 1 months, 3 months and 6 months

The survival criteria is that the gradient of parathyroid hormone reaches 1.5 time or greater by comparing between grafted and non-grafted forearm

次要结局

  • hypoparathyroidism: parathyroid hormone less than 15pg/ml(range from 15 to 65pg/ml)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gaosong Wu

Doctor, Professor

Tongji Hospital

研究点 (1)

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