Brief Title
Fluorescent Cholangiography During Acute Cholecystitis
Official Title
Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis
Brief Summary
This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis
Study Type
Interventional
Primary Outcome
Visualizationrate
Secondary Outcome
Visualizationrate
Condition
Acute Cholecystitis
Intervention
Cholangiography
Study Arms / Comparison Groups
Fluorescent cholangiography
Description: Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
200
Start Date
April 1, 2020
Completion Date
March 1, 2025
Primary Completion Date
March 1, 2024
Eligibility Criteria
Inclusion criteria - Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis with ≤ 5 days of complaints (in Denmark the national consensus for surgical window) Exclusion criteria - Laparoscopic operation converted to open operation prior to completed fluorescent and X-ray cholangiography - Allergy towards iodine, Iohexol or indocyanine green - Legally incompetent (any reason) - Cholangitis (as defined above)15 - Withdrawal of inclusion consent at any time
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT04145869
Organization ID
IFC3
Responsible Party
Principal Investigator
Study Sponsor
Hvidovre University Hospital
Collaborators
Hillerod Hospital, Denmark
Study Sponsor
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Verification Date
April 2020