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

NCT01410734 | Completed DMC

• 1 other identifier: Fluorescence Bliliary ID
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 2

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.

Conditions

Gallbladder Disease; Biliary Colic; Gallstones

Keywords

cholecystectomy; chronic right upper quadrant pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

ICG

EXPERIMENTAL

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)

Interventions

Indocyanine green (ICG) DRUG

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

ICG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intuitive Surgical: lead
• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: collaborator
• University Hospital, Geneva: collaborator

Study Sites (2)

SS Antonio e Biagio e Cesare Arrigo

Alessandria, AL, 15100, Italy

Location

Hospital University Geneva

Geneva, Switzerland

Location

MeSH Terms

Conditions

Gallbladder Diseases; Gallstones

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 5, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

IT (1); CH (1)