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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.
ClinicalTrials.gov, NCT01881399

Sites

  • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital CivilStrasbourg, France