Fluorescent Cholangiography and Bile Duct Stones

Gall Stones, Common Bile Duct Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03530241
• Other study ID #: IFC4
• Status: Withdrawn
• Phase: N/A
• Start date: March 25, 2019
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2024
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2023
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Patients suspected of having bile duct stones by either blood samples, MRCP or medical history (see definitions)
• Patient age = 18 years
• Preoperative MRCP
• Operation performed by a project surgeon Exclusion criteria
• Open cholecystectomy (including conversion from laparoscopic to open)
• Acute cholecytitis or cholangitis
• Pancreatitis
• Iodine or indocyanine green allergy
• Liver or renal insufficiency
• Thyrotoxicosis
• Cholecystectomy not the primary surgical procedure
• Pregnancy or lactation
• Legally incompetent for any reason
• Withdrawal of inclusion consent at any time

Related Conditions & MeSH terms

• Gall Stones, Common Bile Duct
• Gallstones

Intervention

Diagnostic Test:
• Presence of bile duct stones
MRCP verified gall stones in the bile ducts
• Non-presence of bile duct stones
MRCP without bile duct stones

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Holte	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity	Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography	120mins
Secondary	Visualization	Visualization of the extrahepatic bile ducts	120mins