Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery
- Conditions
- Optical ImagingHypoparathyroidismThyroid Cancer
- Interventions
- Device: Near-infrared devicesDiagnostic Test: PTH test strip
- Registration Number
- NCT05684029
- Lead Sponsor
- Fujian Medical University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Patients diagnosed with thyroid cancer by FNA
- Scheduled for surgical treatment
- Patients with papillary thyroid microcarcinoma who ready for radiofrequency ablation or survival monitoring
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Near-infrared Step Near-infrared devices 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. Senior Surgeon Step PTH test strip 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. Near-infrared Step PTH test strip 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳FuZhou, Fujian, China