Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

Not Applicable

Completed

• Conditions: Cholelithiasis; Gallbladder Polyps
• Interventions: Device: Fluorescence cholangiography (da Vinci surgical system); Other: Virtual cholangiography; Procedure: Conventional IOC

• Registration Number: NCT01881399
• Lead Sponsor: IHU Strasbourg

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:

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-17
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-19
• Study Start: 2013-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorescence/Virtual cholangiography/IOC	Virtual cholangiography	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)
Fluorescence/Virtual cholangiography/IOC	Conventional 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)
Fluorescence/Virtual cholangiography/IOC	Fluorescence cholangiography (da Vinci surgical system)	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)

Primary Outcome Measures

Name	Time	Method
To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography	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 Outcome Measures

Name	Time	Method
To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography	Intra-operatively	Time required for fluorescence-based exam, enhanced reality visualization, conventional intraoperative cholangiography Conversion to costs (based on mean cost of OR minute)
To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy	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)
To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction	Intra-operatively	Percentage of patients for whom enhanced reality allows correct identification of biliary tree anatomy,especially the cysticocholedochal junction

Trial Locations

Locations (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France