Clinical trial NCT01410734: Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
Official title: A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Disease
Biliary Colic
Gallstones
Keywords: cholecystectomy
chronic right upper quadrant pain
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
Collaborators: name: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
name: University Hospital, Geneva
First posted: 2011-08-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: intra-operatively
Secondary outcomes:
measure: 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)
timeFrame: within 2 weeks post-operatively
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: SS Antonio e Biagio e Cesare Arrigo
state: AL
city: Geneva
country: Switzerland
facility: Hospital University Geneva
Study officials:
References: