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

Primary Purpose

Cholelithiasis, Gallbladder Polyps

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fluorescence cholangiography (da Vinci surgical system)
Virtual cholangiography
Conventional IOC
Sponsored by
IHU Strasbourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cholelithiasis focused on measuring Cholelithiasis, Gallbladder polyps, Fluorescence, Indocyanine green (ICG), Intraoperative cholangiography (IOC), da Vinci surgical system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluorescence/Virtual cholangiography/IOC

Arm Description

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)

Outcomes

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
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
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
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 required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute)

Full Information

First Posted
June 17, 2013
Last Updated
March 12, 2018
Sponsor
IHU Strasbourg
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1. Study Identification

Unique Protocol Identification Number
NCT01881399
Brief Title
Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy
Acronym
FLARIOC
Official Title
Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IHU Strasbourg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: ease of use lack of invasiveness absence of ionizing radiation to the patient and the operating staff 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis, Gallbladder Polyps
Keywords
Cholelithiasis, Gallbladder polyps, Fluorescence, Indocyanine green (ICG), Intraoperative cholangiography (IOC), da Vinci surgical system

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluorescence/Virtual cholangiography/IOC
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Fluorescence cholangiography (da Vinci surgical system)
Other Intervention Name(s)
da Vinci Si surgical system with da Vinci Fluorescence Imaging Vision System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual cholangiography
Intervention Description
Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.
Intervention Type
Procedure
Intervention Name(s)
Conventional IOC
Intervention Description
Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.
Primary Outcome Measure Information:
Title
To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography
Description
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.
Time Frame
Intra-operatively
Secondary Outcome Measure Information:
Title
To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy
Description
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)
Time Frame
Intra-operatively
Title
To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction
Description
Percentage of patients for whom enhanced reality allows correct identification of biliary tree anatomy,especially the cysticocholedochal junction
Time Frame
Intra-operatively
Title
To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography
Description
Time required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute)
Time Frame
Intra-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Pessaux, Pr
Organizational Affiliation
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28742709
Citation
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.
Results Reference
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Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

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