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WithdrawnNCT03530241Updated Feb 28, 2024

Fluorescent Cholangiography and Bile Duct Stones

An interventional study of Presence of bile duct stones and Non-presence of bile duct stones in Gall Stones, Common Bile Duct, sponsored by Hvidovre University Hospital. Withdrawn at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Hvidovre University Hospital · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
No funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Gall Stones, Common Bile Duct

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Keywords

  • fluorescence
  • cholangiography
  • cholecystectomy, laparoscopic
03

In context

Gallstones

346 studies on the registry are indexed under Gallstones; 46 are open to participants now.

Browse Gallstones studies →

Lead sponsor

Hvidovre University Hospital is the lead sponsor of 295 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    MRCP positive

    Diagnostic Test: Presence of bile duct stones

  • Active comparator
    MRCP negative

    Diagnostic Test: Non-presence of bile duct stones

Interventions

  • Diagnostic testPresence of bile duct stones

    MRCP verified gall stones in the bile ducts

  • Diagnostic testNon-presence of bile duct stones

    MRCP without bile duct stones

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity

    Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography

    Time frame: 120mins

Secondary outcomes

  1. Visualization

    Visualization of the extrahepatic bile ducts

    Time frame: 120mins

07

Study locations

1 site
  • Hvidovre University Hospital
    Holte, Danmark 2840, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03530241
Lead sponsor
Hvidovre University Hospital
Responsible party
Lars Lang Lehrskov (MD, Hvidovre University Hospital) — Principal investigator
First posted
May 21, 2018
Start date
Mar 25, 2019
Primary completion
Oct 31, 2020 (estimated)
Completion
Aug 1, 2023 (estimated)
Last update
Feb 28, 2024

Study contacts

Lars L Lehrskov, MD
principal investigator · Hvidovre University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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