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 Surgical72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gallbladder Disease Biliary Colic Gallstones

Interventions

Indocyanine green (ICG)DRUG

2.5mg indocyanine green (ICG) will be administerly (IV injection) 30 minutes before surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

SS Antonio e Biagio e Cesare Arrigo

Alessandria, AL, Italy

Hospital University Geneva

Geneva, Switzerland

Outcomes

Primary Outcomes

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).

Time frame: intra-operatively

Secondary Outcomes

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)

Time frame: within 2 weeks post-operatively

Data from ClinicalTrials.gov

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