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

This study has been completed.
Sponsor:
Collaborators:
SS.Antonio e Biagio e Cesare Arrigo
University Hospital, Geneva
Information provided by (Responsible Party):
Intuitive Surgical
ClinicalTrials.gov Identifier:
NCT01410734
First received: August 3, 2011
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Gallbladder Disease
Biliary Colic
Gallstones
 Drug: Indocyanine green (ICG)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intuitive Surgical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410734

Locations
Italy
SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL, Italy, 15100
Switzerland
Hospital University Geneva
Geneva, Switzerland
Sponsors and Collaborators
Intuitive Surgical
SS.Antonio e Biagio e Cesare Arrigo
University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Intuitive Surgical
ClinicalTrials.gov Identifier: NCT01410734     History of Changes
Other Study ID Numbers: Fluorescence Bliliary ID
Study First Received: August 3, 2011
Last Updated: December 19, 2012
Health Authority: Italy: Ministry of Health
Switzerland: Swissmedic

Keywords provided by Intuitive Surgical:
cholecystectomy
chronic right upper quadrant pain

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Gallbladder Diseases
 Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013