Fluorescent Cholangiography and Bile Duct Stones
- Conditions
- Gall Stones, Common Bile Duct
- Interventions
- Diagnostic Test: Presence of bile duct stonesDiagnostic Test: Non-presence of bile duct stones
- Registration Number
- NCT03530241
- Lead Sponsor
- Hvidovre University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MRCP positive Presence of bile duct stones - MRCP negative Non-presence of bile duct stones -
- Primary Outcome Measures
Name Time Method Sensitivity and specificity 120mins Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography
- Secondary Outcome Measures
Name Time Method Visualization 120mins Visualization of the extrahepatic bile ducts
Trial Locations
- Locations (1)
Hvidovre University Hospital
🇩🇰Holte, Danmark, Denmark