Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation

Study Overview
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Brief Summary
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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.

Official Title
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Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation

Conditions
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Parathyroid, Intraoperative Monitoring, Thyroid Cancer

Intervention / Treatment
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* Device: Intraoperative parathyroid gland auxiliary recognition system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unilateral thyroid malignancies who require surgical treatment between the ages of 20-50. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naked eyes & Instrument assistance<br>Identify the parathyroid glands through the experience of surgeons and assistance of instrument. | Device: Intraoperative parathyroid gland auxiliary recognition system<br>* The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.<br>|
| No Intervention: Naked eyes only<br>Identify the parathyroid glands only through the experience of surgeons. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Calcium level | Patients' serum Calcium level at 24 hours after surgery. | 24 hours after surgery | 
| Serum Calcium level | Patients' serum Calcium level at 1 month after surgery. | 1 month after surgery | 
| PTH | Patients' serum PTH level at 24 hours after surgery. | 24 hours after surgery | 
| PTH | Patients' serum PTH level at 1 month after surgery. | 1 month after surgery |