Autofluorescence-guided Hemithyroidectomy in a Low-volume, Non-parathyroid Insitution: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Parathyroid gland identification rate
研究概览
简要总结
Parathyroid damage and inadvertent excision unfortunately happens frequently in thyroid surgery. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to be helpful in terms of parathyroid identification and preservation.
In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid centers is needed:
Aim: To investigate the impact of NIRAF on hemithyroidectomy by evaluating parathyroid identification, damage and the rate of inadvertent parathyroid excision in a low-volume, non-parathyroid institution.
详细描述
Patients referred for hemithyroidectomy will be randomized to either:
(A) NIRAF-assisted hemithyroidectomy (Fluobeam LX) or (B) Conventional hemithyroidectomy. PTH and ionized calcium will assessed preoperatively, on postoperative day 1 (POD1) and one month following surgery. Parathyroid identification rates, rates of autoimplantation and inadvertently excised parathyroid glands will be assessed and compared.
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
- Double (Participant, Care Provider)
盲法说明
Patients and related health care staff will be blinded for the allocated intervention until the day of surgery
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
- •Patients referred for thyroid lobectomy
- •Age > 18
- •Able to understand patient information
- •Able to give informed consent
排除标准
- •Completion lobectomy
- •Need for accelerated surgery
- •Age < 18
- •Unable to understand patient information
- •Unable to give informed consent
研究组 & 干预措施
(A): NIRAF-assisted surgery
Patients undergoing NIRAF-assisted hemithyroidectomy
干预措施: Fluobeam LX (Device)
(B): Conventional surgery
Patients undergoing conventional hemithyroidectomy without NIRAF-assistance
干预措施: Conventional surgery without NIRAF assistance (Other)
结局指标
主要结局
Parathyroid gland identification rate
时间窗: Will be assessed at the time of surgery
次要结局
- Rate of autotransplantation(Will be assessed at the time of surgery)
- Rate of inadvertent parathyroid excision(Will be assessed one month following surgery)
研究者
Ali Abood
MD
Regional Hospital West Jutland