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Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery

Completed
Conditions
Optical Imaging
Hypoparathyroidism
Thyroid Cancer
Interventions
Device: Near-infrared devices
Diagnostic 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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Near-infrared StepNear-infrared devices1. 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 StepPTH test strip1. 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 StepPTH test strip1. 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
NameTimeMethod
Suspicious parathyroid tissue found by surgeonsDuring 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 NIFRADuring 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 transplantationDuring 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
NameTimeMethod
inspect durationDuring 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 reportUp 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

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