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NCT Number: NCT01881399

Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

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.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases Gallbladder Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorescence cholangiography (da Vinci surgical system)

Device

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 names: da Vinci Si surgical system with da Vinci Fluorescence Imaging Vision System

Virtual cholangiography

Other

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

Conventional IOC

Procedure

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Official study title

Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study

Acronym: FLARIOC

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 19, 2013
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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