Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery

Study Overview
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Brief Summary
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This is a prospective study aiming to establish near-infrared autofluorescence technology and PTH test strip as a standardized process for finding and identifying parathyroid glands in thyroid surgery.

Detailed Description
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This is a prospective study aiming to establish near-infrared autofluorescence technology and PTH test strip as a standardized process for finding and identifying parathyroid glands in thyroid surgery. NIFRA first photographed all specimens from thyroidectomy with or without central neck dissection, and positive tissues under near-infrared light were recorded in a neck map. Then, a senior surgeon examined the parathyroid glands with the naked eye. These suspicious tissues were then identified with the PTH test strip as a gold standard. Finally, the parathyroid glands discovered during the operation that could not be preserved in situ were excluded from the procedure comparison and classified as strategic parathyroid transplantation.

Official Title
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Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery

Conditions
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Thyroid Cancer, Hypoparathyroidism, Optical Imaging

Intervention / Treatment
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* Device: Near-infrared devices
* Diagnostic Test: PTH test strip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with thyroid cancer by FNA Scheduled for surgical treatment Exclusion Criteria: Patients with papillary thyroid microcarcinoma who ready for radiofrequency ablation or survival monitoring

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Near-infrared Step<br>1. Use near-infrared equipment to detect surgical specimens; 2. Timing near-infrared equipment detects parathyroid glands and takes photography; 3. recording the positive tissue in NIRAF; 4. analyzing the accuracy of NIR equipment to see positive points. | Device: Near-infrared devices<br>* This device can emit and collect near-infrared light of a specific wavelength. The parathyroid glands in the specimen appear as a high-brightness image in the device, to find the parathyroid gland that may be accidentally removed from the specimen.<br>Diagnostic Test: PTH test strip<br>* The PTH test strip is to detect the PTH in the specimen by immunocolloidal gold technology to determine whether it is parathyroid.<br>|
| Senior Surgeon Step<br>1. Senior Surgeon inspects for parathyroid glands in postoperative thyroid specimens with the naked eye; 2. Timing senior doctors with parathyroid glands; 3. PTH test strips confirm all suspicious tissues. 4. all analyzing the accuracy of the positive points of senior doctors. | Diagnostic Test: PTH test strip<br>* The PTH test strip is to detect the PTH in the specimen by immunocolloidal gold technology to determine whether it is parathyroid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive tissue identify by NIFRA | Surgical specimens were photographed with NIRAF, and the location and amount of positive tissue were recorded and marked on the neck map. | During operation, Surgical specimens were photographed with NIRAF, and the location and amount of positive tissue were recorded and marked on the neck map. | 
| Suspicious parathyroid tissue found by surgeons | Surgeons looked for suspicious parathyroid tissue with the naked eye and divided them into less than 10% confidence group, 10-90% confidence group, and greater than 90% confidence group. These tissues are tested with PTH strips to confirm that they are parathyroid tissue. | During operation, Surgeons looked for suspicious parathyroid tissue with the naked eye and These tissues are tested with PTH strips to confirm that they are parathyroid. | 
| number of strategic parathyroid transplantation | The parathyroid glands that had been discovered during the operation that could not be preserved in situ were excluded from the procedure comparison and classified as strategic parathyroid transplantation. | During operation, The parathyroid glands that had been discovered during the operation that could not be preserved in situ were excluded from the procedure comparison and classified as strategic parathyroid transplantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inspect duration | inspect duration in difference method | During operation, From initial examination to finding suspicious parathyroid tissue, excluding subsequent PTH testing steps | 
| The number of parathyroid glands in pathological report | The number of parathyroid glands in pathological report | Up to 4 weeks, The number of parathyroid glands in pathological report excludes fragments of parathyroid glands less than 3mm in diameter. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTH test strip, near-infrared autofluorescence (NIRAF), Thyroid Cancer