Sensitivity and Specificity of Fluorescent Cholangiography to Detect Bile Duct Stones in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity
研究概览
简要总结
Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specificity of IFC for bile duct stone detection.
Research question. What is the sensitivity of IFC to visualize bile duct stones? Method. Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and intraoperative IFC, X-ray cholangiography and choledochuscopy in that order.
Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent cholangiography and secondary outcome is visualization of anatomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MRCP positive
干预措施: Presence of bile duct stones (Diagnostic Test)
MRCP negative
干预措施: Non-presence of bile duct stones (Diagnostic Test)
结局指标
主要结局
Sensitivity and specificity
时间窗: 120mins
Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography
次要结局
- Visualization(120mins)
研究者
Lars Lang Lehrskov
MD
Hvidovre University Hospital