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

Fudan University

Status: Unknown

Conditions: Intraoperative Monitoring; Parathyroid; Thyroid Cancer

Treatments: Device: Intraoperative parathyroid gland auxiliary recognition system

Study type: Interventional

Funder types: Other

Identifiers

NCT04560426

PTIOP1.0

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Naked eyes & Instrument assistance

Experimental group

Description:

Identify the parathyroid glands through the experience of surgeons and assistance of instrument.

Treatment:

Device: Intraoperative parathyroid gland auxiliary recognition system

Naked eyes only

No Intervention group

Description:

Identify the parathyroid glands only through the experience of surgeons.