Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intuitive Surgical
• Collaborators: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo; Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria; University Hospital, Geneva

Criteria

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