Fluorescent Cholangiography and Bile Duct Stones

Study Overview
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Brief Summary
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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.

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

Conditions
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Gall Stones, Common Bile Duct

Intervention / Treatment
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* Diagnostic Test: Presence of bile duct stones
* Diagnostic Test: Non-presence of bile duct stones


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluorescence, cholangiography, cholecystectomy, laparoscopic