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.
Study Type
OBSERVATIONAL
Enrollment
101
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.
The PTH test strip is to detect the PTH in the specimen by immunocolloidal gold technology to determine whether it is parathyroid.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
inspect duration
inspect duration in difference method
Time frame: 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
Time frame: Up to 4 weeks, The number of parathyroid glands in pathological report excludes fragments of parathyroid glands less than 3mm in diameter.
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