This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during total thyroidectomy. It compares risk-benefits and outcomes in patients undergoing total thyroidectomy where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Inadvertent damage or excision of a healthy parathyroid gland (PG) following a total thyroidectomy (TTx) could result in transient hypocalcemia (\< 6 months) in 5 - 35% of cases or permanent hypocalcemia (\> 6 months) in 7% of the patients (1, 2). In both of these circumstances, patients would require calcium and active vitamin D supplementation in addition to a potentially prolonged hospital stay and/or unplanned hospital readmission adding to unnecessary burden and healthcare costs. These complications could be minimized with label-free intraoperative PG identification using near infrared autofluorescence (NIRAF) detection with a fiber-probe based approach as utilized in 'PTeye', which is medical device that was recently FDA-cleared. However, the true impact of this particular NIRAF-based approach on patient outcomes is yet to be determined The aim of this prospective single blinded randomized study is to compare 2 groups of patients: TTx patients operated using NIRAF detection technology with PTeye as adjunct tool (NIRAF+) vs. patients operated without the adjunct technology (NIRAF-). The main objective of this study is to assess the benefit of intraoperative use of NIRAF detection technology via PTeye during TTx procedures with regard to postoperative hypocalcemia, PG identification, PG auto-transplantation and inadvertent resection rates compared to standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid. Other Name: PTeye Device
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Subjects With Transient Hypoparathyroidism.
The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level \<10 pg/mL.
Time frame: 24-48 hours post-op
Patients With Hypoparathyroidism at Last Follow-up
The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range.
Time frame: 2 days to 1 year after surgery
Overall Average Number of Parathyroid Glands Identified With High Confidence.
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
Time frame: Immediate (during total thyroidectomy, up to 3 hours)
Number of Participants With Frozen Sections Sent for Analysis.
Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue.
Time frame: Immediate (during total thyroidectomy, up to 3 hours)
Number of Participants With Auto-transplanted Parathyroid Glands
Number of participants with auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Time frame: Immediate (during total thyroidectomy, up to 3 hours)
Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy
Number of participants who spent nights for postoperative recovery in the hospital after the surgical procedure.
Time frame: 0-72 hours after total thyroidectomy
Number of Participants With Inadvertently Resected Parathyroid Glands
Number of participants with inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.
Time frame: Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report)
Number of Doctor Visits/Emergency Department Visits or Hospital Admissions
Number of doctor visits/emergency department visits or hospital admissions due to hypocalcemia and or associated symptoms.
Time frame: Up to 6 months after total thyroidectomy
Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery
Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation.
Time frame: Up to 6 months after total thyroidectomy
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