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Fluorescent Cholangiography and Bile Duct Stones

NCT03530241 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-02-28

No results posted yet for this 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.

Conditions

  • Gall Stones, Common Bile Duct

Interventions

DIAGNOSTIC_TEST

Presence of bile duct stones

MRCP verified gall stones in the bile ducts

DIAGNOSTIC_TEST

Non-presence of bile duct stones

MRCP without bile duct stones

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Lars L Lehrskov, MD · Hvidovre University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2020-10-31
Completion
2023-08-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03530241 on ClinicalTrials.gov