Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

NCT ID: NCT01881399

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-06-30

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.

Conditions

Cholelithiasis; Gallbladder Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fluorescence/Virtual cholangiography/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)

Group Type: EXPERIMENTAL

Fluorescence cholangiography (da Vinci surgical system)

Intervention Type: 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.

Virtual cholangiography

Intervention Type: OTHER

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

Conventional IOC

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

Virtual cholangiography

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

Intervention Type: OTHER

Conventional IOC

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

Intervention Type: PROCEDURE

Other Intervention Names

da Vinci Si surgical system with da Vinci Fluorescence Imaging Vision System

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IHU Strasbourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Pessaux, Pr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 28742709 (View on PubMed)

Other Identifiers

2012-A01664-39

Identifier Type: OTHER

Identifier Source: secondary_id

12-004

Identifier Type: -

Identifier Source: org_study_id