Status:
COMPLETED
Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy
Lead Sponsor:
IHU Strasbourg
Conditions:
Cholelithiasis
Gallbladder Polyps
Eligibility:
All Genders
18+ years
Phase:
NA
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 rang...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01881399
Start Date
November 1 2013
End Date
June 1 2016
Last Update
March 14 2018
Active Locations (1)
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1
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, France, 67000