Near-infrared autofluorescence of the parathyroid glands during thyroidectomy for the prevention of hypoparathyroidism: a prospective randomized clinical trial

PURPOSE: Postoperative hypoparathyroidism remains the most often complication in thyroid surgery. Near-infrared autofluorescence (NIR-AF) is a modality to identify parathyroid glands (PG) in vivo with high accuracy, but its use in daily routine surgery is unclear so far. In this randomized controlled trial, we evaluate the ability of NIR-AF to prevent postoperative hypoparathyroidism following total thyroidectomy. METHODS: Patients undergoing total thyroidectomy were allocated in two groups with the use of NIR-AF in the intervention group or according to standard practice in the control group. The aim was to identify the PGs in an early most stage of the operation to prevent their devascularization or removal. Parathyroid hormone was measured pre- and postoperatively and on postoperative day (POD) 1. Serum calcium was measured on POD 1 and 2. Possible symptoms and calcium/calcitriol supplement were recorded. RESULTS: A total of 60 patients were randomized, of whom 30 underwent NIR-AF-based PG identification. Hypoparathyroidism at skin closure occurred in 7 out of 30 patients using NIR-AF, respectively, in 14 out of 30 patients in the control group (p=0.058). There was no significant difference in serum calcium and parathyroid hormone levels between both groups. Likewise, NIR-AF could not detect PGs at a higher rate. CONCLUSION: The use of NIR-AF may help surgeons identify and preserve PGs but did not significantly reduce the incidence of postoperative hypoparathyroidism in this trial. Larger case series have to clarify whether there is a benefit in routine thyroidectomy. TRIAL REGISTRATION NUMBER: DRKS00009242 (German Clinical Trial Register). Registration date: 03.09.2015