Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides
 real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as
 identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile
 duct (CBD). Irradiation given to the patient during a classic cholangiography can be reduced.
Up to 40 patients will be prospectively enrolled in this multi-centre (up to 5 centres)
 single arm study. After given consent, patients will undergo minimally invasive
 cholecystectomy with da Vinci Fluorescence Imaging using Indocynine green (ICG) and near
 infra-red light (NIR) to identify the surgically relevant anatomy of the biliary tree during
 this procedure.

 Efficacy endpoints The efficacy of the da Vinci Fluorescence Imaging Vision System to
 identify biliary anatomy will be demonstrated by successful detection (90%) of one or more of
 the following biliary vessels: Cystic duct, common hepatic duct (CHD) or common bile duct
 (CBD).

 Safety endpoints To observe and report peri-operative safety outcomes, including but not
 limited to incidence of adverse events and allergic reactions (rare according to the current
 knowledge and applications). Safety endpoints will be met by affirming the safety profile of
 the procedure, compared to currently available literature.
Inclusion Criteria:

 -  Informed consent

 -  Ages of 18 to 80 years.

 -  Symptoms consistent with gallbladder disease including biliary colic or chronic right
 upper quadrant pain.

 -  Ultrasound confirming gallstones

 Exclusion Criteria:

 -  Acute cholecystitis

 -  Biliary pancreatitis

 -  Suspicion of common bile duct stones.

 -  Pregnancy.

 -  Previous upper abdominal open surgeries.

 -  Severe lack of cooperation by patient due to psychological or severe systemic illness.

 -  The presence of medical conditions contraindicating general anesthesia or standard
 surgical approaches.

 -  Subject has a previous history of adverse reaction or allergy to ICG, iodine products
 (or excipient), shellfish or iodine dyes

 -  Surgery converted to non-robotic procedures, such as open surgery or laparoscopic
 surgery