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Randomized Controlled Trial
. 2025 Sep 1;160(9):936-944.
doi: 10.1001/jamasurg.2025.2233.

Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial

Alexandria G Cousart  1   2 , Colleen M Kiernan  3 , Parker A Willmon  1   2 , Giju Thomas  1   2 , Tracy S Wang  4 , Paul G Gauger  5 , Quan-Yang Duh  6 , Hunter J Underwood  5 , Anee Jackson  5 , Anuradha Patel  3 , Anita Mahadevan-Jansen  1   2   3 , Carmen C Solórzano  3
Affiliations
Randomized Controlled Trial

Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial

Alexandria G Cousart et al. JAMA Surg. .

Abstract

Importance: Inadvertent removal and damage to parathyroid glands (PGs) can lead to hypoparathyroidism, making it crucial to accurately identify and preserve these glands during parathyroidectomy and thyroidectomy.

Objective: To assess if fiber-based near-infrared autofluorescence (NIRAF) increases the number of intraoperatively identified PGs and reduces the occurrence of hypoparathyroidism.

Design, setting, and participants: This multicenter randomized clinical trial with a 6-month follow-up was conducted between March 2020 and July 2024. It included 4 medical centers across the US, 4 senior (more than 10 years of experience) and 3 junior (less than 5 years of experience) surgeons. A total of 754 patients were enrolled and 752 were randomized, including 398 patients (2 withdrew) who underwent parathyroidectomy and 354 patients who had total/completion thyroidectomy. Data were analyzed from March 2020 to January 2025.

Interventions: Use of fiber-based NIRAF during thyroidectomy and parathyroidectomy.

Main outcomes and measures: The primary outcome was the mean number of PGs identified intraoperatively. The secondary outcome was the rate of hypoparathyroidism (transient and at last follow-up).

Results: Of 752 patients randomized, 712 were analyzed for the primary outcome (94.4%) (overall median [IQR] age, 59 [25] years; 516 females [68.4%]). A total of 161 underwent parathyroidectomy with NIRAF, while 159 had conventional surgery. Additionally, 176 underwent thyroidectomy using NIRAF and 178 had traditional surgery. The mean number of PGs identified during parathyroidectomy was not significantly higher when using NIRAF for focused procedures (mean, NIRAF, 1.6; 95% CI, 1.4-1.8 vs control, 1.5; 95% CI, 1.4-1.7). During bilateral explorations, the surgeons improved in the mean number of PGs identified when using NIRAF (mean NIRAF, 3.5; 95% CI, 3.4-3.7 vs control, 3.2; 95% CI, 3.0-3.4; P < .001). During thyroidectomy, the mean number of PGs identified increased when using NIRAF (mean NIRAF, 3.3; 95% CI, 3.2-3.4 vs control, 2.8; 95% CI, 2.7-3.0; P < .001). There was no significant difference in hypoparathyroidism after thyroidectomy, either transient (NIRAF: 48 of 173 patients [27.8%]; control: 44 of 169 patients [26%]) or at the last follow-up (NIRAF: 3 of 176 patients [1.7%]; control: 6 of 176 patients [3.4%]).

Conclusions and relevance: Fiber-based NIRAF can increase the number of PGs identified during thyroidectomy and bilateral exploration parathyroidectomy without increasing the duration of the surgery.

Trial registration: ClinicalTrials.gov Identifiers: NCT05579782, NCT05022667, NCT05022641, NCT04281875, NCT04299425, NCT05152927.

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Conflict of interest statement

Conflict of Interest Disclosures: Ms Cousart reported grants from the National Institutes of Health during the conduct of the study and that Vanderbilt University has a licensing agreement with Medtronic for the PTeye device. Dr Kiernan reported grants from the National Institutes of Health subcontracted to Vanderbilt University and nonfinancial support from Vanderbilt University for the PTeye device and probes during the conduct of the study. Dr Willmon reported nonfinancial support from Medtronic, which has a licensing agreement with Vanderbilt for the utilized technology during the conduct of the study. Dr Thomas reported grants from the National Institute of Health during the conduct of the study. Dr Jackson reported nonfinancial support from Vanderbilt University for the PTeye device and probes and clinical research support during the conduct of the study. Dr Patel reported grants from the National Institutes of Health subcontracted to Vanderbilt University and nonfinancial support from Vanderbilt University for the PTeye device and probes during the conduct of the study. Dr Mahadevan-Jansen reported grants from the National Institutes of Health as principal investigator for the development of near-infrared autofluorescence and nonfinancial support from Medtronic for the PTeye units and probes under an external research program during the conduct of the study and grants from the National Institutes of Health for nerve imaging in endocrine surgery that is unrelated to and outside the submitted work; in addition, Dr Mahadevan-Jansen has a patent on near-infrared autofluorescence for parathyroid identification licensed to Medtronic. Dr Solórzano reported nonfinancial support from Vanderbilt University for the PTeye device and probes and clinical research support during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Trial Flowchart
Figure 2.
Figure 2.. Changes in Surgeon Confidence
Surgeon confidence (high >75%, medium >50%, or low <50%) before near-infrared autofluorescence (NIRAF), after NIRAF, and control.
See this image and copyright information in PMC

Comment on

References

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