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

March 12, 2018 updated by: IHU Strasbourg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67000
        • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intra-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Intra-operatively
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
Intra-operatively
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)
Intra-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IHU Strasbourg

Investigators

  • Principal Investigator: Patrick Pessaux, Pr, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

June 17, 2013

First Posted (ESTIMATE)

June 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-004
  • 2012-A01664-39 (OTHER: ANSM France)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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