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

Not Applicable

• Conditions: Intraoperative Monitoring; Thyroid Cancer; Parathyroid
• Interventions: Device: Intraoperative parathyroid gland auxiliary recognition system

• Registration Number: NCT04560426
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-29
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-23
• Last Update Posted: 2020-09-23
• Study Start: 2020-10-31
• Primary Completion: 2021-10-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients with unilateral thyroid malignancies who require surgical treatment between the ages of 20-50.
2. No history of neck surgery and radiotherapy.
3. There is no evidence of parathyroid tumor invasion in preoperative imaging assessment.
4. No abnormal calcium metabolism disease.
5. No abnormalities in blood calcium and blood PTH before operation.
6. No allergy to contrast agents.
7. The patient or his agent signs an informed consent statement.

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Exclusion Criteria

1. Does not meet the entry criteria;
2. Parathyroid glands were found to be invaded by tumor during operation and the parathyroid glands could not be preserved.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naked eyes & Instrument assistance	Intraoperative parathyroid gland auxiliary recognition system	Identify the parathyroid glands through the experience of surgeons and assistance of instrument.

Primary Outcome Measures

Name	Time	Method
PTH	1 month after surgery	Patients' serum PTH level at 1 month after surgery.
Serum Calcium level	1 month after surgery	Patients' serum Calcium level at 1 month after surgery.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China