WHITE CAP Trial: Optical Parathyroid Tissue Sensor-Guided Assessment of Parathyroid Viability and Its Impact on Clinical Decision-Making
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of Transient Hypocalcaemia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Calcium and PTH assays will be processed and adjudicated by blinded laboratory personnel; investigators assessing primary endpoint are unaware of group assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Pregnancy or breastfeeding.
- •Inability to tolerate general anaesthesia or contraindication to intra-operative PTS imaging.
结局指标
主要结局
Incidence of Transient Hypocalcaemia
时间窗: Baseline to 48 hours after surgery (Post-op Day 0-2)
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.
次要结局
- Permanent Hypocalcaemia(6 months (±14 days) post-op)
- Parathyroid Hormone (PTH) Recovery ≥ 15 pg/mL(24 hours post-op)
- Operative Time(Intra-operative (minutes))
- Estimated Blood Loss(Intra-operative (mL))
- Biochemical or Clinical Recurrence(12 to 24 months post-op)
- Correlation of NIRAF Intensity with PTH Recovery(Intra-op & 24 hours post-op)
研究者
Bo Wang,MD
Director & Head of Thyroid Surgery, Principal Investigator, Clinical Professor
Fujian Medical University Union Hospital