Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-03-25
2023-08-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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MRCP positive
Presence of bile duct stones
MRCP verified gall stones in the bile ducts
MRCP negative
Non-presence of bile duct stones
MRCP without bile duct stones
Interventions
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Presence of bile duct stones
MRCP verified gall stones in the bile ducts
Non-presence of bile duct stones
MRCP without bile duct stones
Eligibility Criteria
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Inclusion Criteria
* Patient age ≥ 18 years
* Preoperative MRCP
* Operation performed by a project surgeon
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Lars Lang Lehrskov
MD
Principal Investigators
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Lars L Lehrskov, MD
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital
Locations
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Hvidovre University Hospital
Holte, Danmark, Denmark
Countries
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Other Identifiers
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IFC4
Identifier Type: -
Identifier Source: org_study_id
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