Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery Can Prevent Post-thyroidectomy Hypoparathyroidism
试验速览
- 阶段
- 不适用
- 入组人数
- 214
- 试验地点
- 4
- 主要终点
- Postoperative hypoparathyroidism
研究概览
简要总结
The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.
详细描述
Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to:
- Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence.
- Control: Conventional thyroidectomy and parathyroid identification by the surgeon.
Measurements:
PTH and ionized-Ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up.
Anticipated 214 patients are included, all of which participate in 3 months follow-up. Only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand patient information and to give written informed consent
- •Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.
排除标准
- •Not able to understand patient information and to give written informed consent
- •Previous parathyroid surgery or other parathyroid decease
- •Age under 18
结局指标
主要结局
Postoperative hypoparathyroidism
时间窗: 24 months-follow-up
Hypoparathyroidism defined as: PTH \< 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline
次要结局
- Parathyroidglands identified by NIR light(During surgery)
- Time(Immediately after surgery)
- Postoperative hypocalcemia(12 months follow-up)
研究者
Eva Lykke
Principal investigator
Rigshospitalet, Denmark