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

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

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.

Study Overview

• Status: Completed
• Conditions: Gallstones; Biliary Colic; Gallbladder Disease
• Intervention / Treatment: Drug: Indocyanine green (ICG)

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • AL
    • Alessandria, AL, Italy, 15100
      • SS Antonio e Biagio e Cesare Arrigo
• Switzerland
  • Geneva, Switzerland
    • Hospital University Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Indocyanine green (ICG); 2.5mg indocyanine green (ICG) will be administerly (IV injection) 30 minutes before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	intra-operatively

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	within 2 weeks post-operatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: August 4, 2011
• First Posted (Estimate): August 5, 2011

Study Record Updates

• Last Update Posted (Estimate): December 20, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: cholecystectomy; chronic right upper quadrant pain
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Calculi; Cholelithiasis; Cholecystolithiasis; Gallstones; Gallbladder Diseases
• Other Study ID Numbers: Fluorescence Bliliary ID