Clinical trial NCT01881399: Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy
Official title: Fluorescence Cholangiography Versus Conventional Intraoperative Cholangiography for Visualization of Biliary Tract Anatomy : a Prospective, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Gallbladder Polyps
Keywords: Cholelithiasis
Gallbladder polyps
Fluorescence
Indocyanine green (ICG)
Intraoperative cholangiography (IOC)
da Vinci surgical system
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

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

Primary outcomes:
measure: To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography
timeFrame: Intra-operatively
Secondary outcomes:
measure: To evaluate the ability of fluorescence-based imaging in visualizing the biliary tree anatomy
timeFrame: Intra-operatively
measure: To evaluate the ability of enhanced reality in visualizing the biliary anatomy intra-operatively, especially the cysticocholedochal junction
timeFrame: Intra-operatively
measure: To evaluate time required for the visualization of biliary tree anatomy for each modality : fluorescence, enhanced reality, conventional intraoperative cholangiography
timeFrame: Intra-operatively
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
name: Patrick Pessaux, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.