NCT01881399

Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: IHU Strasbourg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholelithiasis
• Gallbladder Polyps

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2013-06-19
• Last updated: 2018-03-14

Locations

1 site across 1 country: France