Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

Cholelithiasis Clinical Trial

— FLARIOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881399
• Other study ID #: 12-004
• Secondary ID: 2012-A01664-39
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: March 12, 2018
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: March 2018
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallbladder Polyps
• Gallstones

Intervention

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:
• 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.

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (1)

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 Intra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intra-operatively
Secondary	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)	Intra-operatively
Secondary	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	Intra-operatively
Secondary	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)	Intra-operatively