Fluorescent Cholangiography During Acute Cholecystitis

February 26, 2024 updated by: Lars Lang Lehrskov, Hvidovre University Hospital

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Zealand University Hospital Køge
    • Danmark
      • Hillerød, Danmark, Denmark, 3400
        • Northzealand Hospiral Hillerød
      • Hvidovre, Danmark, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluorescent cholangiography
Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green
Procedure: Cholangiography
All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography
Active Comparator: X-ray cholangiography
Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol
Procedure: Cholangiography
All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualizationrate
Time Frame: 1 hour
Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour
Bile duct stones
Time Frame: 1 hour
Percentage of patients with visualization of bile duct stones
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Zealand University Hospital
Hillerod Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFC3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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