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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by IHU Strasbourg
Sponsor:
Information provided by (Responsible Party):
IHU Strasbourg
ClinicalTrials.gov Identifier:
NCT01881399
First received: June 17, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention
Cholelithiasis
Gallbladder Polyps
Device: Fluorescence cholangiography (da Vinci surgical system)
Other: Virtual cholangiography
Procedure: Conventional IOC

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study

Resource links provided by NLM:


Further study details as provided by IHU Strasbourg:

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

    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:
  • To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy [ Time Frame: Intra-operatively ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute)


Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluorescence/Virtual cholangiography/IOC

Prior to cholecystectomy, patients will undergo:

  • Fluorescence cholangiography (visualization following 0.5 mg/kg ICG)
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881399

Contacts
Contact: Patrick Pessaux, Pr +33 3 69 55 05 52 patrick.pessaux@chru-strasbourg.fr

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

No publications provided

Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT01881399     History of Changes
Other Study ID Numbers: 12-004, 2012-A01664-39
Study First Received: June 17, 2013
Last Updated: June 24, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by IHU Strasbourg:
Cholelithiasis
Gallbladder polyps
Fluorescence
Indocyanine green (ICG)
Intraoperative cholangiography (IOC)
da Vinci surgical system

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

ClinicalTrials.gov processed this record on September 18, 2014