Background and Rationale Near-infrared autofluorescence (NIRAF) highlights parathyroid tissue at a wavelength of 820 nm. Several devices, including Fluobeam LX and PTeye®, have FDA 510(k) clearance for intra-operative identification of parathyroid glands. In \~70 % of single-gland disease, NIRAF shows a viable rim of normal tissue partially encasing the adenoma. Retrospective data conflict on whether rim preservation reduces transient hypocalcaemia or increases recurrence. No prospective randomized evidence exists.
Objectives Primary: Compare the incidence of transient hypocalcaemia (albumin-corrected Ca \< 2.00 mmol·L-¹ or need for calcium/vit-D supplementation) within 48 h post-operative between preservation and en-bloc strategies.
Secondary: (i) Permanent hypocalcaemia at 6 months; (ii) PTH ≥ 15 pg·mL-¹ at 24 h; (iii) operative time and blood loss; (iv) biochemical or clinical recurrence up to 24 months; (v) correlation of quantitative NIRAF intensity with gland viability.
Study Design Multicentre, parallel-group, 1:1 randomized controlled trial (RCT). Block randomisation (size 4) stratified by centre and baseline vitamin-D status. Total sample 120 participants (60 per arm, includes 10 % attrition). Single-blind: outcome assessors and laboratory staff remain unaware of allocation.
Interventions Preservation arm: After adenoma excision, surgeon confirms NIRAF-positive rim and leaves it in situ; only minimal defatting to ensure vascularity.
En-bloc arm: Adenoma plus NIRAF-positive rim excised en bloc. If fewer than two normal glands remain in the neck, a 30 mg fragment is minced and autotransplanted into the non-dominant brachioradialis.
Eligibility Inclusion: age 18-75 y; biochemically confirmed primary hyperparathyroidism; imaging (MIBI or 4D-CT) concordant with a solitary adenoma; written informed consent.
Exclusion: multiple endocrine neoplasia, \>1 enlarged gland on imaging, eGFR \< 30, pregnancy, neck re-exploration, planned concomitant total thyroidectomy.
Outcome Assessments Serum Ca, phosphate, Mg, PTH measured pre-op; 6 h, 24 h, 48 h; Day 7; Months 1, 6, 12, 24. Laryngoscopy if voice change occurs. Recurrence defined as Ca above upper limit plus PTH \> 65 pg·mL-¹ after Month 12. NIRAF intensity recorded (arbitrary units) using standard ROI software.
Statistical Plan Transient hypocalcaemia expected 30 % in en-bloc vs 10 % in preservation. With α = 0.05, 1-β = 0.80, needs 54 per arm; rounded to 60. Intent-to-treat analysis. Risk ratios with 95 % CI; secondary continuous outcomes by mixed-effects ANCOVA. Interim safety review at 50 % recruitment (O'Brien-Fleming boundary).
Regulatory and Ethics PTS devices are FDA-cleared; study classified as non-significant-risk device research exempt from IDE (21 CFR 812.2(b)). All centres have IRB approval. Data stored in REDCap, anonymised, GDPR-compliant. A three-member DSMB (endocrine surgeon, endocrinologist, biostatistician) will monitor AEs; trial pause if permanent hypocalcaemia exceeds 15 %.
Data Sharing De-identified participant data and analytic code will be available upon reasonable request 6 months after primary publication.
