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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01664-39 | Other Identifier | ANSM France |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence/Virtual cholangiography/IOC | Experimental | Prior to cholecystectomy, patients will undergo:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence cholangiography (da Vinci surgical system) | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Non inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Pessaux, Pr | Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil | Strasbourg | 67000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28742709 | Result | Diana M, Soler L, Agnus V, D'Urso A, Vix M, Dallemagne B, Faucher V, Roy C, Mutter D, Marescaux J, Pessaux P. Prospective Evaluation of Precision Multimodal Gallbladder Surgery Navigation: Virtual Reality, Near-infrared Fluorescence, and X-ray-based Intraoperative Cholangiography. Ann Surg. 2017 Nov;266(5):890-897. doi: 10.1097/SLA.0000000000002400. |
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| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| Virtual cholangiography | Other | Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence. |
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| Conventional IOC | Procedure | Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging. |
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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 |