Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy
- Conditions
- Thyroid DiseasePostoperative HypoparathyroidismThyroid CancerThyroid Neoplasms
- Interventions
- Device: NIRAF Detection Technology
- Registration Number
- NCT05579782
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
(i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid).
(ii) All patients undergoing completion thyroidectomy.
(i) Patients with concurrent parathyroid disease.
(ii) Patients with incidental enlarged parathyroid discovered during TTx.
(iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NIRAF Detection Technology (+) NIRAF Detection Technology Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
- Primary Outcome Measures
Name Time Method Postoperative hypoparathyroidism/hypocalcemia (Immediate) Within 24 hours of surgery The number of subjects with 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
Postoperative hypoparathyroidism/hypocalcemia (Transient) 5-14 days after total thyroidectomy The number of subjects with 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 5-14 days after total thyroidectomy).
Postoperative hypoparathyroidism/hypocalcemia (Permanent) 6 months after total thyroidectomy The number of subjects with permanent hypoparathyroidism, which is hypocalcemia that persists and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month.
- Secondary Outcome Measures
Name Time Method Number of parathyroid glands identified with NIRAF Immediate (during total thyroidectomy) Number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye.
Number of auto-transplanted parathyroid glands Immediate (during total thyroidectomy) Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Number of doctor visits/emergency department visits or hospital admissions Up to 6 months after total thyroidectomy Number of doctor visits/emergency department visits or hospital admissions due to hypocalcemia and or associated symptoms.
Number of nights spent in the hospital after total thyroidectomy 0-72 hours after total thyroidectomy Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Number of inadvertently resected parathyroid glands Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report) Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.
Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery Up to 6 months after total thyroidectomy Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation.
Overall number of parathyroid glands identified Immediate (during total thyroidectomy) Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
Number of frozen sections sent for analysis. Immediate (during total thyroidectomy) Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Trial Locations
- Locations (1)
Froedtert Hospital and Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States