Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient
研究概览
简要总结
This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
详细描述
Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.
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
- •Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).
- •Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.
排除标准
- •Pregnant women
- •Patients with concurrent parathyroid and thyroid disease
- •Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure.
- •Patients undergoing thyroid lobectomy or partial thyroidectomy
结局指标
主要结局
The Average Number of Parathyroid Glands Identified (Experimental Group: Glands Identified With Naked Eye + NIRAF; Control Group: Glands Identified With Naked Eye) Per Patient
时间窗: Immediate (During total thyroidectomy procedure)
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
次要结局
- Blood Parathyroid Hormone (PTH) Levels at 5-14 Days After Surgery(5-14 days after surgery)
- Blood Parathyroid Hormone (PTH) Levels at 24-48 Hours After Surgery(Within 24-48 hours after surgery)
- Blood Calcium Levels 24-48 Hours After Surgery(Within 24-48 hours after surgery)
- Duration in Minutes of Surgery(Collected immediately following surgery)
- Number of Frozen Section Analysis Performed.(Collected immediately following surgery)
- Number of Auto-transplanted Parathyroid Glands(Immediate. During total thyroidectomy procedure)
- Number of Nights Spent in the Hospital After Total Thyroidectomy(0 - 4 nights after total thyroidectomy)
- Number of Inadvertently Resected Parathyroid Glands(Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report))
研究者
Paul Gauger
Ambulatory Care Clinical Chief, William J Fry Professor of Surgery and Professor of Surgery, Medical School
University of Michigan