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

IHU Strasbourg

Status: Completed

Conditions: Cholelithiasis; Gallbladder Polyps

Treatments: Procedure: Conventional IOC; Other: Virtual cholangiography; Device: Fluorescence cholangiography (da Vinci surgical system)

Study type: Interventional

Funder types: Other

Identifiers

NCT01881399

2012-A01664-39 (Other Identifier)

12-004

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Fluorescence/Virtual cholangiography/IOC

Experimental group

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)

Treatment:

Other: Virtual cholangiography

Procedure: Conventional IOC

Device: Fluorescence cholangiography (da Vinci surgical system)