Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy (FLARIOC)
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|ClinicalTrials.gov Identifier: NCT01881399|
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : March 14, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholelithiasis Gallbladder Polyps||Device: Fluorescence cholangiography (da Vinci surgical system) Other: Virtual cholangiography Procedure: Conventional IOC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: Fluorescence/Virtual cholangiography/IOC
Prior to cholecystectomy, patients will undergo:
Device: Fluorescence 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.
Other Name: da Vinci Si surgical system with da Vinci Fluorescence Imaging Vision System
Other: Virtual cholangiography
Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.
Procedure: Conventional IOC
Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.
- To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography [ Time Frame: 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.
- To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Intra-operatively ]Time required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881399
|Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil|
|Strasbourg, France, 67000|
|Principal Investigator:||Patrick Pessaux, Pr||Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg|