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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04560426
• Other study ID #: PTIOP1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 31, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: September 2020
• Source: Fudan University
• Contact: Yu Wang, Doctor
• Phone: +86 13817311886
• Email: neck130[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intraoperative Monitoring
• Neoplasms
• Parathyroid
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Device:
• Intraoperative parathyroid gland auxiliary recognition system
The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Calcium level	Patients' serum Calcium level at 24 hours after surgery.	24 hours after surgery
Primary	Serum Calcium level	Patients' serum Calcium level at 1 month after surgery.	1 month after surgery
Primary	PTH	Patients' serum PTH level at 24 hours after surgery.	24 hours after surgery
Primary	PTH	Patients' serum PTH level at 1 month after surgery.	1 month after surgery