Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Device: NIRAF Detection Technology
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
|
| No Intervention: NIRAF Detection Technology (-) Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). |
Outcome Measures
Primary Outcome Measures
- Postoperative hypoparathyroidism/hypocalcemia (Immediate) [Within 24 hours of surgery]
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]
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]
If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if hypocalcemia persists and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month.
Secondary Outcome Measures
- 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 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 frozen sections sent for analysis. [Immediate (during total thyroidectomy)]
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)]
Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
- Number of nights spent in the hospital after total thyroidectomy [0-72 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.
- 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.
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Froedtert Hospital and Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Medical College of Wisconsin
- National Cancer Institute (NCI)
- Vanderbilt University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00040572