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

NCT ID: NCT01410734

Last Updated: 2012-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-12-31

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.

Conditions

Gallbladder Disease; Biliary Colic; Gallstones

Keywords

cholecystectomy; chronic right upper quadrant pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ICG

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.

Group Type: EXPERIMENTAL

Indocyanine green (ICG)

Intervention Type: DRUG

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

Interventions

Indocyanine green (ICG)

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Intuitive Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SS Antonio e Biagio e Cesare Arrigo

Alessandria, AL, Italy

Hospital University Geneva

Geneva, , Switzerland

Countries

Italy; Switzerland

Other Identifiers

Fluorescence Bliliary ID

Identifier Type: -

Identifier Source: org_study_id