Cholelithiasis, Gallbladder Polyps
Conditions
Keywords
Cholelithiasis, Gallbladder polyps, Fluorescence, Indocyanine green (ICG), Intraoperative cholangiography (IOC), da Vinci surgical system
Brief summary
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: 1. ease of use 2. lack of invasiveness 3. absence of ionizing radiation to the patient and the operating staff 4. 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.
Interventions
DEVICEFluorescence cholangiography (da Vinci surgical system)
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.
OTHERVirtual cholangiography
Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.
PROCEDUREConventional IOC
Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.
Sponsors
IHU Strasbourg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography | Intra-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy | Intra-operatively | 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) |
| To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction | Intra-operatively | Percentage of patients for whom enhanced reality allows correct identification of biliary tree anatomy,especially the cysticocholedochal junction |
| To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography | Intra-operatively | Time required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute) |
Countries
France
Outcome results
None listed