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

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.