NCT03386201Unknown不适用
FLuorescence Cholangiography Using Methylene Blue
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Concordance of surgeon anatomy definition with fluorescence outline
研究概览
简要总结
Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 years or above.
- •Undergoing laparoscopic cholecystectomy
排除标准
- •Patient who is unable or unwilling to give informed consent
- •Known allergy to methylene blue
- •Risk of serotonin syndrome (taking SSRI / G6PD deficiency / previous serotonin syndrome)
- •Significant renal failure
- •Pregnant / planning pregnancy or breastfeeding
研究组 & 干预措施
Intravenous methylene blue
Experimental
干预措施: Intravenous Methylene blue (Drug)
结局指标
主要结局
Concordance of surgeon anatomy definition with fluorescence outline
时间窗: Intraoperative (At end of laparoscopic cholecystectomy)
次要结局
- Signal to background ratio over time throughout laparoscopic cholecystectomy(0, 10, 20, 30, 40, 50, 60, minutes and at 10 minute intervals thereafter post injection of methylene blue)
研究者
DrThomasBarnes
Clinical Research Fellow
University of Oxford
研究点 (1)
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