Clinical trial NCT05684029: Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery
Official title: Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Hypoparathyroidism
Optical Imaging
Keywords: PTH test strip
near-infrared autofluorescence (NIRAF)
Thyroid Cancer
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 101
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with thyroid cancer by FNA and scheduled for surgical treatment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive tissue identify by NIFRA
timeFrame: During operation, Surgical specimens were photographed with NIRAF, and the location and amount of positive tissue were recorded and marked on the neck map.
measure: Suspicious parathyroid tissue found by surgeons
timeFrame: 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.
measure: number of strategic parathyroid transplantation
timeFrame: 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 outcomes:
measure: inspect duration
timeFrame: During operation, From initial examination to finding suspicious parathyroid tissue, excluding subsequent PTH testing steps
measure: The number of parathyroid glands in pathological report
timeFrame: Up to 4 weeks, The number of parathyroid glands in pathological report excludes fragments of parathyroid glands less than 3mm in diameter.
Other outcomes:
Locations:
city: FuZhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References: