Finished
Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy
NCT01881399 · IHU Strasbourg · Updated 14 March 2018
- What is being tested
- Fluorescence cholangiography (da Vinci surgical system); Virtual cholangiography; Conventional IOC
- For
- Cholelithiasis; Gallbladder Polyps
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 66 people. The full rules are on the registry page.
- Where
- France
- When
- Starts or started Nov 2013, ends June 2016. Registered 19 June 2013.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital CivilStrasbourg, France
