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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.