Primary hyperparathyroidism is usually cured by removing the single over-active parathyroid adenoma. During surgery, however, surgeons often see a thin rim of normal parathyroid tissue that still "glows" under a near-infrared parathyroid tissue sensor (PTS). It is unclear whether keeping this tissue in place helps preserve hormone function or whether it leaves behind cells that could become over-active again.
The WHITE CAP study will compare two common surgical choices:
Preservation strategy - the surgeon removes only the adenoma and leaves the glowing rim of normal tissue untouched.
En-bloc strategy - the surgeon removes the adenoma together with the glowing rim; if too little parathyroid tissue remains, a small fragment is transplanted into the forearm muscle.
About 120 adult patients who have a single parathyroid adenoma will be randomly assigned (like tossing a coin) to one of the two strategies. All operations will use the same FDA-cleared PTS camera that shows the glands in real time without dye or radiation.
The main question is whether preserving the normal rim lowers the rate of temporary low blood-calcium (numbness, tingling) during the first two days after surgery. The study will also check long-term results-blood calcium and parathyroid hormone (PTH) levels, symptoms, and any return of the disease-over two years.
The PTS imaging itself is painless and adds only a few minutes to the operation. Risks are the same as for standard parathyroid surgery, and participants can withdraw at any time without affecting their usual care.
Age 18 to 75 years, able to give informed consent.
Biochemically proven primary hyperparathyroidism (elevated serum calcium and inappropriately high PTH).
Pre-operative imaging (sestamibi scan, 4-phase CT, or ultrasound) concordant with a single parathyroid adenoma.
Planned minimally invasive parathyroidectomy using near-infrared parathyroid tissue sensor (PTS) guidance.
Multiple endocrine neoplasia (MEN 1 or 2) or suspicion of multi-gland disease (>1 enlarged gland on imaging).
Prior parathyroid or extensive neck surgery causing distorted anatomy.
Need for simultaneous total thyroidectomy or other major neck procedure.
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².
Parallel
Near-Infrared Parathyroid Tissue Sensor Imaging (PTS)
DeviceFDA-cleared imager (e.g., Fluobeam LX/PTeye) providing real-time autofluorescence to identify parathyroid tissue during surgery; no dye or radiation.
Rim-Preservation Technique
Procedure/SurgerySurgical excision of adenoma while leaving the NIRAF-positive rim of normal parathyroid tissue in situ; minimal defatting to ensure perfusion.
En-bloc Resection Technique
Procedure/SurgerySurgical excision of adenoma together with the surrounding NIRAF-positive rim; autotransplant fragment if \< 2 normal glands remain in neck.
Incidence of Transient Hypocalcaemia
Proportion of participants whose albumin-corrected serum calcium falls \< 2.00 mmol/L or who require oral/IV calcium ± active vitamin D to maintain normocalcaemia within 48 h post-operatively. Blood samples at 6 h, 24 h, and 48 h will be analysed by a blinded central laboratory.
Permanent Hypocalcaemia
Need for ongoing calcium ± calcitriol to maintain normocalcaemia at ≥ 6 months after surgery.
Parathyroid Hormone (PTH) Recovery ≥ 15 pg/mL
Percentage of patients with serum PTH ≥ 15 pg/mL at 24 h, indicating preserved parathyroid function.
Operative Time
Skin incision to skin closure, recorded by anaesthesia time stamp.
Estimated Blood Loss
Calculated from suction canister minus irrigation plus soaked swab weight.
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Fujian Medical University
Lead sponsor
Fujian Medical University Union Hospital
Sponsor institution
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