Fluorescence Imaging for the Detection and Perfusion of the Parathyroid Glands of Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Quantification of the fluorescent signal of ICG
研究概览
简要总结
The aim of this study is to develop a standardized and user-independent imaging workflow model for autofluorescence and quantified fluorescence angiography with Indocyanine Green (ICG) of the parathyroid glands of children. For this purpose, all pediatric patients will undergo thyroid surgery with the use of autofluorescence and quantified ICG-fluorescence.
This study could be the first step in reducing the rate of postoperative hypocalcemia in children, by using fluorescence angiography during pediatric thyroid surgery.
详细描述
Background:
Children with thyroid cancer have excellent survival rates. However, postoperative hypocalcemia, due to inadvertent excision of the parathyroid glands or damage to their vasculature during thyroid surgery, is a severe complication which occurs in 24% - 67% of the children with thyroid cancer and causes lifelong reduced quality of life and increased morbidity rates. In adults, intraoperative identification of the parathyroid glands with autofluorescence and assessment of their perfusion using quantified ICG-fluorescence angiography has shown to reduce postoperative hypocalcemia. However, in children no studies regarding quantified fluorescence of the parathyroid glands have been conducted. There is a clear need for surgical techniques to identify and preserve the parathyroid glands during thyroid surgery in children.
Therefore, the aim of this study is to develop a standardized imaging workflow model for autofluorescence and quantified ICG-angiography of the parathyroid glands in children. This workflow model can be the first step in reducing the rate of postoperative hypocalcemia in children.
Study design:
This will be a prospective, observational, multicenter, feasibility study. The aim is to generate the patterns of intraoperative autofluorescence and quantified ICG-fluorescence angiography of the parathyroid glands in children, resulting in a user-independent, standardized imaging workflow model for autofluorescence and quantified ICG-angiography of the parathyroid glands of children.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients <18 years
- •Patients undergoing total thyroidectomy (for any indication)
- •Patients undergoing lobectomy for the suspicion of a malignancy, with a subsequent completion thyroidectomy
- •Written informed consent (from parents/caregivers, patients or both, see chapter 6.0)
排除标准
- •Patients with preoperative hypo - or hypercalcemia, treated for hypo- or hypercalcemia, (chronic) renal disease, kidney transplantation or any disorder that requires calcium supplementation (other than standard preoperative calcium supplementation for a total thyroidectomy).
- •Patients with known allergy to ICG or iodinated contrast
- •Pregnancy or breastfeeding
- •Patients with severe liver dysfunction
- •Preterm neonates
- •Newborn infants with an indication for exchange transfusion for severe neonatal hyperbilirubinemia
结局指标
主要结局
Quantification of the fluorescent signal of ICG
时间窗: During thyroid surgery
Quantification of the fluorescent signal of ICG
Number and location of autofluorescent parathyroid glands
时间窗: During thyroid surgery
Number and location of autofluorescent parathyroid glands
Postoperative hypocalcemia
时间窗: Postoperative day 1-3 and first out-patient clinic visit (between day 1 and day 10 postoperative)
Postoperative hypocalcemia
次要结局
未报告次要终点
研究者
Daniël van de Berg, MD
MD
Amsterdam UMC, location VUmc