NCT03530241

Fluorescent Cholangiography and Bile Duct Stones

Sensitivity and Specificity of Fluorescent Cholangiography to Detect Bile Duct Stones in Patients Undergoing Laparoscopic Cholecystectomy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hvidovre University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gall Stones, Common Bile Duct

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Presence of bile duct stones	MRCP verified gall stones in the bile ducts
DIAGNOSTIC_TEST	Non-presence of bile duct stones	MRCP without bile duct stones

Timeline

• Start date: 2019-03-25
• Primary completion: 2020-10-31
• Completion: 2023-08-01
• First posted: 2018-05-21
• Last updated: 2024-02-28

Locations

1 site across 1 country: Denmark