Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

Study Overview
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Brief Summary
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The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI. Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages: ease of use lack of invasiveness absence of ionizing radiation to the patient and the operating staff performed prior to any dissection (prior to critical view of safety) Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study. The study requires a 2-month patient participation.

Official Title
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Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study

Conditions
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Cholelithiasis, Gallbladder Polyps

Intervention / Treatment
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* Device: Fluorescence cholangiography (da Vinci surgical system)
* Other: Virtual cholangiography
* Procedure: Conventional IOC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman > 18 years old Symptomatic gallbladder lithiasis or gallbladder polyps Clinical, biological ou medical imaging history leading to suspicion of gallstones migration Absence of contra-indication to anesthesia and cholecystectomy procedure Ability to understand the study related information and to provide written informed consent Registered with the French social security regime Non inclusion Criteria: Inability to give informed consent Acute Cholecystitis Contraindications to MRI exam (claustrophobia, implantable devices) Potential risk of allergic reactions to iodine-containing contrast agents, to indocyanine green or other fluorescent compounds Pregnancy or breast-feeding Exclusion period from other clinical trial Forfeit freedom from an administrative or legal obligation Under guardianship

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescence/Virtual cholangiography/IOC<br>Prior to cholecystectomy, patients will undergo: Fluorescence cholangiography (visualization following up to a maximum of 0.5 mg/kg ICG - usually 10 ml of 0,5 mg/ml solution) Virtual cholangiography (enhanced-reality) superimposed on fluorescence images Conventional IOC (intraoperative cholangiography) | Device: Fluorescence cholangiography (da Vinci surgical system)<br>* Patients will received IV injection of ICG intra-operatively, allowing surgeons to view bile ducts under fluorescence imaging using the da Vinci surgical system with fluorescence Imaging system.<br>* Other names: da Vinci Si surgical system with da Vinci Fluorescence Imaging Vision System;Other: Virtual cholangiography<br>* Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.<br>Procedure: Conventional IOC<br>* Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography | Percentage of patients for whom fluorescence allows for cysticocholedochal junction with precision at least as good as intraoperative cholangiography (identification of anatomical details and information). Independent aposteriori evaluation performed by a radiologist/surgeon team. | Intra-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy | Percentage of patients for whom fluorescence-based imaging allows correct identification of biliary tree anatomy (anatomical variant, cystic duct stones, bile duct stones, dilated ducts) | Intra-operatively | 
| To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction | Percentage of patients for whom enhanced reality allows correct identification of biliary tree anatomy,especially the cysticocholedochal junction | Intra-operatively | 
| To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography | Time required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute) | Intra-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholelithiasis, Gallbladder polyps, Fluorescence, Indocyanine green (ICG), Intraoperative cholangiography (IOC), da Vinci surgical system