Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 241
- 试验地点
- 6
- 主要终点
- Postoperative hypocalcemia
研究概览
简要总结
This Multicenter, Randomized Controlled Trial evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (NIR) during total thyroidectomy (TT). It compares patients who undergo TT associated or not with lymph node dissection (LND) with NIR vs without NIR use during surgery.
详细描述
Total thyroidectomy (TT) is responsible for postoperative hypocalcemia in 20-30% of patients, which is definitive in 1-4% of operated patients (1). This complication is mainly due to surgery-induced parathyroid dysfunction, which could be improved by a better intraoperative identification of the parathyroids. Intraoperative parathyroid auto-fluorescence visualization (without any dye injection) using near infrared light (NIR) is an emerging technique, which allows correct identification of normal parathyroids in almost all cases (2), but the clinical impact of NIR is unknown.
The aim of this prospective, comparative randomized study, is to compare 2 groups of patients: patients operated with NIR (NIR+) vs patients operated without NIR (NIR-).
The main objective of this study is to assess the impact of intraoperative use of NIR camera on postoperative hypocalcemia. Secondary objectives are to assess the impact of NIR on the visualization, autotransplantation and inadvertent resection rates during TT.
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
- •All patients eligible for one-stage total thyroidectomy, associated or not to lymph node dissection (TT +/- LND).
排除标准
- •Combined parathyroid and thyroid disease (including patients with enlarged parathyroids incidentally found during surgery and resected)
研究组 & 干预措施
NIR+ group
Patients who undergo conventional total thyroidectomy (TT)+/- lymph node dissection (LND).
Parathyroid identification was done with the use of NIR (intervention group, NIR+ group)
干预措施: Near Infrared Camera (NIR) (Device)
NIR- group
Patients who undergo conventional total thyroidectomy (TT)+/- lymph node dissection (LND) without the use of NIR - parathyroid identification was done by naked eye only (no intervention group, NIR- group)
结局指标
主要结局
Postoperative hypocalcemia
时间窗: 6 months
Postoperative day 1 and day 2 corrected calcemia (hypocalcemia when calcemia \<2mmol/l). If hypocalcemia, calcium is measured at 1 month and 6 months
次要结局
- Number of identified parathyroids(immediate (intraoperative))
- Number of autotransplanted parathyroids(immediate (intraoperative))
- Number of inadvertently resected parathyroids(delayed (10 days))
研究者
Fares BENMILOUD
MD
Hôpital Européen Marseille