Back to resultsFluorescent Cholangiography During Acute Cholecystitis
Primary Purpose
Acute Cholecystitis
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cholangiography
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis focused on measuring Fluorescence, Cholangriography, Cholecystectomy
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
Sites / Locations
- Northzealand Hospiral Hillerød
- Hvidovre University Hospital
- Zealand University Hospital Køge
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fluorescent cholangiography
X-ray cholangiography
Arm Description
Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green
Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol
Outcomes
Primary Outcome Measures
Visualizationrate
Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction.
Secondary Outcome Measures
Visualizationrate
Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct
Bile duct stones
Percentage of patients with visualization of bile duct stones
Full Information
NCT ID
NCT04145869
First Posted
October 29, 2019
Last Updated
April 1, 2020
Sponsor
Hvidovre University Hospital
Collaborators
Hillerod Hospital, Denmark, Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04145869
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Hillerod Hospital, Denmark, Zealand University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
Fluorescence, Cholangriography, Cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluorescent cholangiography
Arm Type
Experimental
Arm Description
Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green
Arm Title
X-ray cholangiography
Arm Type
Active Comparator
Arm Description
Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol
Intervention Type
Procedure
Intervention Name(s)
Cholangiography
Intervention Description
All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography
Primary Outcome Measure Information:
Title
Visualizationrate
Description
Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Visualizationrate
Description
Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct
Time Frame
1 hour
Title
Bile duct stones
Description
Percentage of patients with visualization of bile duct stones
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Northzealand Hospiral Hillerød
City
Hillerød
State/Province
Danmark
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Hvidovre University Hospital
City
Hvidovre
State/Province
Danmark
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Zealand University Hospital Køge
City
Køge
ZIP/Postal Code
4600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Fluorescent Cholangiography During Acute Cholecystitis
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