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Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy (FLARIOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01881399
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : March 14, 2018
Information provided by (Responsible Party):
IHU Strasbourg

Brief Summary:

The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI.

Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:

  1. ease of use
  2. lack of invasiveness
  3. absence of ionizing radiation to the patient and the operating staff
  4. performed prior to any dissection (prior to "critical view of safety")

Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study.

The study requires a 2-month patient participation.

Condition or disease Intervention/treatment Phase
Cholelithiasis Gallbladder Polyps Device: Fluorescence cholangiography (da Vinci surgical system) Other: Virtual cholangiography Procedure: Conventional IOC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study
Study Start Date : November 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy

Arm Intervention/treatment
Experimental: Fluorescence/Virtual cholangiography/IOC

Prior to cholecystectomy, patients will undergo:

  • Fluorescence cholangiography (visualization following up to a maximum of 0.5 mg/kg ICG - usually 10 ml of 0,5 mg/ml solution)
  • Virtual cholangiography (enhanced-reality) superimposed on fluorescence images
  • Conventional IOC (intraoperative cholangiography)
Device: Fluorescence cholangiography (da Vinci surgical system)
Patients will received IV injection of ICG intra-operatively, allowing surgeons to view bile ducts under fluorescence imaging using the da Vinci surgical system with fluorescence Imaging system.
Other Name: da Vinci Si surgical system with da Vinci Fluorescence Imaging Vision System

Other: Virtual cholangiography
Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.

Procedure: Conventional IOC
Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.

Primary Outcome Measures :
  1. To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography [ Time Frame: Intra-operatively ]

    Percentage of patients for whom fluorescence allows for cysticocholedochal junction with precision at least as good as intraoperative cholangiography (identification of anatomical details and information).

    Independent aposteriori evaluation performed by a radiologist/surgeon team.

Secondary Outcome Measures :
  1. To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy [ Time Frame: Intra-operatively ]
    Percentage of patients for whom fluorescence-based imaging allows correct identification of biliary tree anatomy (anatomical variant, cystic duct stones, bile duct stones, dilated ducts)

  2. To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction [ Time Frame: Intra-operatively ]
    Percentage of patients for whom enhanced reality allows correct identification of biliary tree anatomy,especially the cysticocholedochal junction

  3. To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography [ Time Frame: Intra-operatively ]
    Time required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Man or woman > 18 years old
  • Symptomatic gallbladder lithiasis or gallbladder polyps
  • Clinical, biological ou medical imaging history leading to suspicion of gallstones migration
  • Absence of contra-indication to anesthesia and cholecystectomy procedure
  • Ability to understand the study related information and to provide written informed consent
  • Registered with the French social security regime

Non inclusion Criteria:

  • Inability to give informed consent
  • Acute Cholecystitis
  • Contraindications to MRI exam (claustrophobia, implantable devices)
  • Potential risk of allergic reactions to iodine-containing contrast agents, to indocyanine green or other fluorescent compounds
  • Pregnancy or breast-feeding
  • Exclusion period from other clinical trial
  • Forfeit freedom from an administrative or legal obligation
  • Under guardianship

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01881399

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Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, France, 67000
Sponsors and Collaborators
IHU Strasbourg
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Principal Investigator: Patrick Pessaux, Pr Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Publications of Results:
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Responsible Party: IHU Strasbourg Identifier: NCT01881399     History of Changes
Other Study ID Numbers: 12-004
2012-A01664-39 ( Other Identifier: ANSM France )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Keywords provided by IHU Strasbourg:
Gallbladder polyps
Indocyanine green (ICG)
Intraoperative cholangiography (IOC)
da Vinci surgical system
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases