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

Intuitive Surgical

Status: Completed

Conditions: Gallstones; Biliary Colic; Gallbladder Disease

Treatments: Drug: Indocyanine green (ICG)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01410734

Fluorescence Bliliary ID

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

ICG

Experimental group

Description:

Patient will received IV injection of ICG intra-operatively. Surgeon will view bile ducts under fluorescence imaging mode to see if ICG helps to identify biliary ducts.

Treatment:

Drug: Indocyanine green (ICG)