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 (PGs) during total thyroidectomy (TTx). It compares risk-benefits and outcomes in TTx patients 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 (3 - 5) as utilized in 'PTeye', which is medical device that was recently FDA-cleared (6). 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
160
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.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Average Number of Parathyroid Glands Identified With High Confidence Per Patient
Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
Time frame: Immediate. During total thyroidectomy procedure.
Postoperative Hypoparathyroidism/Hypocalcemia (Permanent)
If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level and/or PTH is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if PTH \< 16 pg/mL and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month.
Time frame: 6 months after total thyroidectomy
Postoperative Hypoparathyroidism/Hypocalcemia (Transient)
Undetectable postoperative PTH and/or low calcium (total calcium \< 2mmol/L or 8 mg/dL, serum intact PTH \< 16 pg/mL or 1 pmol/L) at first postoperative visit (usually 5-30 days after total thyroidectomy).
Time frame: 5 days to 6 months after total thyroidectomy.
Postoperative Hypoparathyroidism/Hypocalcemia (Immediate)
Postoperative low calcium (total calcium \<8mg/dL or \<2mmol/L) and/or undetectable parathyroid hormone (PTH) (serum intact PTH \< 16 pg/mL or 1 pmol/L) within 24 hours after surgery
Time frame: Within 24 hours after total thyroidectomy.
Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue).
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Time frame: Immediate. During total thyroidectomy procedure.
Number of Auto-transplanted Parathyroid Glands
Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Time frame: Immediate. During total thyroidectomy procedure.
Number of Nights Spent in the Hospital After Total Thyroidectomy
Number of nights spent in the hospital after the surgical procedure. 0 nights, 1 night, \>1 night
Time frame: 0 - 4 nights after total thyroidectomy
Number of Inadvertently Resected Parathyroid Glands
Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.
Time frame: Intraoperatively or on histology (within 24 hours post operation)
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