Hypoparathyroidism, Optical Imaging, Thyroid Cancer
Conditions
Keywords
PTH test strip, near-infrared autofluorescence (NIRAF), Thyroid Cancer
Brief summary
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
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.
Interventions
DEVICENear-infrared devices
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.
DIAGNOSTIC_TESTPTH test strip
The PTH test strip is to detect the PTH in the specimen by immunocolloidal gold technology to determine whether it is parathyroid.
Sponsors
Fujian Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive tissue identify by NIFRA | During operation, Surgical specimens were photographed with NIRAF, and the location and amount of positive tissue were recorded and marked on the neck map. | 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 | 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. | 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. |
| number of 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| inspect duration | During operation, From initial examination to finding suspicious parathyroid tissue, excluding subsequent PTH testing steps | inspect duration in difference method |
| 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. | The number of parathyroid glands in pathological report |
Countries
China
Outcome results
None listed