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NCT04145869 Clinical Trial

Fluorescent Cholangiography During Acute Cholecystitis

Acute Cholecystitis Clinical Trial

Official title:
Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04145869
Other study ID # IFC3
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date March 1, 2025

Study information
Verified date February 2024
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date March 1, 2025
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cholangiography
All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography

Locations
Country Name City State
Denmark Northzealand Hospiral Hillerød Hillerød Danmark
Denmark Hvidovre University Hospital Hvidovre Danmark
Denmark Zealand University Hospital Køge Køge

Sponsors (3)
Lead Sponsor Collaborator
Hvidovre University Hospital Hillerod Hospital, Denmark, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visualizationrate Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction. 1 hour
Secondary Visualizationrate Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct 1 hour
Secondary Bile duct stones Percentage of patients with visualization of bile duct stones 1 hour
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