Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Average Number of Parathyroid Glands Identified With High Confidence Per Patient
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Masking Description
Only participants will be masked to the intervention.
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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).
Intervention: NIRAF Detection Technology (Device)
NIRAF Detection Technology -
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
Outcomes
Primary Outcomes
Average Number of Parathyroid Glands Identified With High Confidence Per Patient
Time Frame: 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 Outcomes
- Postoperative Hypoparathyroidism/Hypocalcemia (Permanent)(6 months after total thyroidectomy)
- Postoperative Hypoparathyroidism/Hypocalcemia (Transient)(5 days to 6 months after total thyroidectomy.)
- Postoperative Hypoparathyroidism/Hypocalcemia (Immediate)(Within 24 hours after total thyroidectomy.)
- Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue).(Immediate. During total thyroidectomy procedure.)
- Number of Auto-transplanted Parathyroid Glands(Immediate. During total thyroidectomy procedure.)
- Number of Nights Spent in the Hospital After Total Thyroidectomy(0 - 4 nights after total thyroidectomy)
- Number of Inadvertently Resected Parathyroid Glands(Intraoperatively or on histology (within 24 hours post operation))
Investigators
Carmen Solorzano
Professor of Surgery Chair, Department of Surgery Director, Vanderbilt Endocrine Surgery
Vanderbilt-Ingram Cancer Center