Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

NCT01881399 | Completed

• 2 other identifiers: 12-0042012-A01664-39
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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. 1.ease of use
2. 2.lack of invasiveness
3. 3.absence of ionizing radiation to the patient and the operating staff
4. 4.performed prior to any dissection (prior to "critical view of safety")

Conditions

Cholelithiasis; Gallbladder Polyps

Keywords

Cholelithiasis; Gallbladder polyps; Fluorescence; Indocyanine green (ICG); Intraoperative cholangiography (IOC); da Vinci surgical system

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy

  Intra-operatively

• To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, 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

  Intra-operatively

Study Arms (1)

Fluorescence/Virtual cholangiography/IOC

EXPERIMENTAL

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); Other: Virtual cholangiography; Procedure: Conventional IOC

Interventions

Fluorescence cholangiography (da Vinci surgical system) DEVICE

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.

Also known as: da Vinci Si surgical system with da Vinci Fluorescence Imaging Vision System

Fluorescence/Virtual cholangiography/IOC

Virtual cholangiography OTHER

Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.

Fluorescence/Virtual cholangiography/IOC

Conventional IOC PROCEDURE

Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.

Fluorescence/Virtual cholangiography/IOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Forfeit freedom from an administrative or legal obligation
• Under guardianship

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

Related 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 Intraoperative Cholangiography. Ann Surg. 2017 Nov;266(5):890-897. doi: 10.1097/SLA.0000000000002400.

  PMID: 28742709 RESULT

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Patrick Pessaux, Pr

  Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 19, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

FR (1)