Does the use of probe-based near infrared autofluorescence parathyroid detection benefit parathyroidectomy? A randomized single-center clinical trial
Colleen M. Kiernan*1, Giju Thomas2, Parker Willmon2, Taylor St. Amour1, Anuradha Patel1, Carmen C. Solorzano1
1Vanderbilt University Medical Center, Nashville, TN; 2Vanderbilt University, Nashville, TN
Objectives: Intraoperative parathyroid gland identification during parathyroidectomy can be challenging. This may lead to protracted procedures, while additionally requiring costly frozen sections. Earlier studies have successfully established near-infrared autofluorescence (NIRAF) detection as a reliable intraoperative adjunct for parathyroid identification. This study reports the first randomized clinical trial to evaluate the benefits of probe-based NIRAF parathyroid detection during parathyroidectomy. For this study, a FDA-cleared probe-based NIRAF detection device, called Parathyroid-eye (PTeye), was investigated as the intervention. Methods: Patients undergoing parathyroidectomy for primary hyperparathyroidism were prospectively enrolled in equal numbers by a senior surgeon (>20 years experience) and a junior surgeon (<5 years experience), while being randomly allocated to the intervention (NIRAF) or control (no NIRAF) group. Data collected included procedure type (focused vs. bilateral exploration), number of parathyroids identified with high confidence (>75% confident) by the surgeon, number of parathyroids identified with high confidence by the trainee, number of frozen sections, operative time, and number of patients with hypercalcemia at the first post-operative visit. Results: One hundred and sixty patients were randomly enrolled under both surgeons to the NIRAF group (n=80) vs. control (n=80). With plain visual inspection, the junior and senior attending surgeons identified 2.7 and 2.7 parathyroids per patient with high confidence in the NIRAF and control group, respectively (P=.89). With NIRAF detection in the intervention group, parathyroid identification rate of the senior surgeon improved significantly from 3.2 pre-NIRAF detection to 3.6 parathyroid glands per patient post-NIRAF detection (P<.001), while that of the junior surgeon also rose significantly from 2.2 pre-NIRAF detection to 2.5 parathyroids per patient post-NIRAF detection (P=.001). Parathyroid identification for trainees also increased from 0.9 to 2.9 parathyroids per patient (P<.001). There was a significant reduction in frozen section use in the NIRAF group vs. the controls for both the senior surgeon (4 vs. 18 frozen sections per group, P=.05) and junior surgeon (9 vs. 26 frozen sections per group, P=.03). No significant difference was observed for operative time between the NIRAF and control groups for the senior surgeon (90 vs. 86 min, P=.65). There was a significant reduction in operative time for the junior surgeon (87 vs. 104 min, P=.03). There was no significant difference in the number of patients with persistent hypercalcemia at the first postoperative visit between the NIRAF and control groups (P=.86). Conclusions: Probe-based NIRAF detection can be a valuable intraoperative adjunct and educational tool for improving parathyroid gland identification, while potentially reducing the number of frozen sections and duration of parathyroidectomy procedures.
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