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

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ClinicalTrials.gov Identifier: NCT01881399
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg

June 17, 2013
June 19, 2013
March 14, 2018
November 2013
June 2016   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01881399 on ClinicalTrials.gov Archive Site
  • 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)
  • 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
  • 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)
Same as current
Not Provided
Not Provided
 
Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy
Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study

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.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Cholelithiasis
  • Gallbladder Polyps
  • 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.
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)
Interventions:
  • Device: Fluorescence cholangiography (da Vinci surgical system)
  • Other: Virtual cholangiography
  • Procedure: Conventional IOC
Diana M, Soler L, Agnus V, D'Urso A, Vix M, Dallemagne B, Faucher V, Roy C, Mutter D, Marescaux J, Pessaux P. Prospective Evaluation of Precision Multimodal Gallbladder Surgery Navigation: Virtual Reality, Near-infrared Fluorescence, and X-ray-based Intraoperative Cholangiography. Ann Surg. 2017 Nov;266(5):890-897. doi: 10.1097/SLA.0000000000002400.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
60
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01881399
12-004
2012-A01664-39 ( Other Identifier: ANSM France )
No
Not Provided
Not Provided
IHU Strasbourg
IHU Strasbourg
Not Provided
Principal Investigator: Patrick Pessaux, Pr Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
IHU Strasbourg
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP