Fluorescent Cholangiography and Bile Duct Stones

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

Sensitivity and Specificity of Fluorescent Cholangiography to Detect Bile Duct Stones in Patients Undergoing Laparoscopic Cholecystectomy

Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specificity of IFC for bile duct stone detection.

Research question. What is the sensitivity of IFC to visualize bile duct stones? Method. Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and intraoperative IFC, X-ray cholangiography and choledochuscopy in that order.

Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent cholangiography and secondary outcome is visualization of anatomy.

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Withdrawn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
    • Danmark
      • Holte, Danmark, Denmark, 2840
        • 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Patients suspected of having bile duct stones by either blood samples, MRCP or medical history (see definitions)
  • Patient age ≥ 18 years
  • Preoperative MRCP
  • Operation performed by a project surgeon

Exclusion criteria

  • Open cholecystectomy (including conversion from laparoscopic to open)
  • Acute cholecytitis or cholangitis
  • Pancreatitis
  • Iodine or indocyanine green allergy
  • Liver or renal insufficiency
  • Thyrotoxicosis
  • Cholecystectomy not the primary surgical procedure
  • Pregnancy or lactation
  • Legally incompetent for any reason
  • 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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRCP positive
Diagnostic test: Presence of bile duct stones
MRCP verified gall stones in the bile ducts
Active Comparator: MRCP negative
Diagnostic test: Non-presence of bile duct stones
MRCP without bile duct stones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity
Time Frame: 120mins
Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography
120mins

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualization
Time Frame: 120mins
Visualization of the extrahepatic bile ducts
120mins

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Lars L Lehrskov, MD, Hvidovre University Hospital

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)

March 25, 2019

Primary Completion (Estimated)

October 31, 2020

Study Completion (Estimated)

August 1, 2023

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

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

  • IFC4

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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