Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PTH
研究概览
简要总结
This intraoperative parathyroid gland auxiliary recognition system uses the principle of parathyroid gland autofluorescence to assist surgeons in accurately identifying and protecting parathyroid glands during surgery, reducing the possibility of postoperative hypoparathyroidism. This study will explore the protective effect of the parathyroid gland auxiliary recognition instrument on parathyroid function during thyroid malignant tumor surgery through reasonable grouping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unilateral thyroid malignancies who require surgical treatment between the ages of 20-
- •No history of neck surgery and radiotherapy.
- •There is no evidence of parathyroid tumor invasion in preoperative imaging assessment.
- •No abnormal calcium metabolism disease.
- •No abnormalities in blood calcium and blood PTH before operation.
- •No allergy to contrast agents.
- •The patient or his agent signs an informed consent statement.
排除标准
- •Does not meet the entry criteria;
- •Parathyroid glands were found to be invaded by tumor during operation and the parathyroid glands could not be preserved.
研究组 & 干预措施
Naked eyes & Instrument assistance
Identify the parathyroid glands through the experience of surgeons and assistance of instrument.
干预措施: Intraoperative parathyroid gland auxiliary recognition system (Device)
Naked eyes only
Identify the parathyroid glands only through the experience of surgeons.
结局指标
主要结局
PTH
时间窗: 1 month after surgery
Patients' serum PTH level at 1 month after surgery.
Serum Calcium level
时间窗: 1 month after surgery
Patients' serum Calcium level at 1 month after surgery.
Serum Calcium level
时间窗: 24 hours after surgery
Patients' serum Calcium level at 24 hours after surgery.
PTH
时间窗: 24 hours after surgery
Patients' serum PTH level at 24 hours after surgery.
次要结局
未报告次要终点