Fluorescent Cholangiography During Acute Cholecystitis
Overview
This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis
Full Title of Study: “Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 1, 2024
Interventions
- Procedure: Cholangiography
- All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography
Arms, Groups and Cohorts
- Experimental: Fluorescent cholangiography
- Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green
- Active Comparator: X-ray cholangiography
- Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol
Clinical Trial Outcome Measures
Primary Measures
- Visualizationrate
- Time Frame: 1 hour
- Percentage of patients with visualization of the structure: the cystic duct – common hepatic duct – common bile duct junction.
Secondary Measures
- Visualizationrate
- Time Frame: 1 hour
- Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct
- Bile duct stones
- Time Frame: 1 hour
- Percentage of patients with visualization of bile duct stones
Participating in This Clinical Trial
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 Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Hvidovre University Hospital
- Collaborator
- Hillerod Hospital, Denmark
- Provider of Information About this Clinical Study
- Principal Investigator: Lars Lang Lehrskov, Principal investigator – Hvidovre University Hospital
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