Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy.

Not Applicable

Completed

Conditions: Thyroid Neoplasms
Postoperative Hypoparathyroidism
Thyroid Cancer

Interventions: Device: NIRAF Detection Technology

Registration Number: NCT04281875

Lead Sponsor: Vanderbilt-Ingram Cancer Center

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 (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.

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 (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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

Inclusion Criteria

(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.

Exclusion Criteria

(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
Average Number of Parathyroid Glands Identified With High Confidence Per Patient	Immediate. During total thyroidectomy procedure.	Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient

Secondary Outcome Measures

Name	Time	Method
Postoperative Hypoparathyroidism/Hypocalcemia (Permanent)	6 months after total thyroidectomy	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.
Postoperative Hypoparathyroidism/Hypocalcemia (Transient)	5 days to 6 months after total thyroidectomy.	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).
Postoperative Hypoparathyroidism/Hypocalcemia (Immediate)	Within 24 hours after total thyroidectomy.	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
Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue).	Immediate. During total thyroidectomy procedure.	Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Number of Auto-transplanted Parathyroid Glands	Immediate. During total thyroidectomy procedure.	Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Number of Nights Spent in the Hospital After Total Thyroidectomy	0 - 4 nights after total thyroidectomy	Number of nights spent in the hospital after the surgical procedure. 0 nights, 1 night, \>1 night
Number of Inadvertently Resected Parathyroid Glands	Intraoperatively or on histology (within 24 hours post operation)	Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.