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

• Sponsor: Fudan University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04560426
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parathyroid; Intraoperative Monitoring; Thyroid Cancer	Device: Intraoperative parathyroid gland auxiliary recognition system	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Protective Effect of Intraoperative Parathyroid Gland Auxiliary Recognition System in Thyroid Malignant Tumor Operation
• Anticipated Study Start Date: Oct 31, 2020
• Anticipated Primary Completion Date: Oct 31, 2021
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naked eyes & Instrument assistance Identify the parathyroid glands through the experience of surgeons and assistance of instrument.	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.
No Intervention: Naked eyes only Identify the parathyroid glands only through the experience of surgeons.

Outcome Measures

Primary Outcome Measures

1. Serum Calcium level [24 hours after surgery]

   Patients' serum Calcium level at 24 hours after surgery.

2. Serum Calcium level [1 month after surgery]

   Patients' serum Calcium level at 1 month after surgery.

3. PTH [24 hours after surgery]

   Patients' serum PTH level at 24 hours after surgery.

4. PTH [1 month after surgery]

   Patients' serum PTH level at 1 month after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200000

Sponsors and Collaborators

• Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fudan University
• ClinicalTrials.gov Identifier: NCT04560426
• Other Study ID Numbers: PTIOP1.0
• First Posted: Sep 23, 2020
• Last Update Posted: Sep 23, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Thyroid Neoplasms; Neoplasms; Thyroid Diseases; Parathyroid Hormone

Study Results

No Results Posted as of Sep 23, 2020