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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Near-infrared Step | 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. |
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| Senior Surgeon Step | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near-infrared devices | Device | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with thyroid cancer by FNA and scheduled for surgical treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350001 | China |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D007011 | Hypoparathyroidism |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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Thyroid surgical specimens, including the thyroid gland, central compartment lymph nodes, and adipose tissue, may include ischemic parathyroid glands. These parathyroid glands, if exist, will transplant back into the patient's body after they are identified.
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| PTH test strip | Diagnostic Test | The PTH test strip is to detect the PTH in the specimen by immunocolloidal gold technology to determine whether it is parathyroid. |
|
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. |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D010279 | Parathyroid Diseases |