Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Primary objective:
Obtain a tissular characterization of a biliary or pancreatic stenosis with a confocal
microscope which is in direct contact of the stenosis during the Endoscopic Retrograde
Cholangio-Pancreatography (ERCP).
Secondary objectives:
- Compare the result of this "optical biopsy" to a conventional biopsy.
- Tolerance
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
The principal outcome is the percentage of successful in vivo examination according to the localisation of the stenosis. A successful examination is defined by the obtention of exploitable image for the anatomopathology.
2 days
No
Marc GIOVANNINI, MD
Principal Investigator
Institut Paoli-Calmettes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
EMID/IPC 2008-001
NCT00930410
September 2008
May 2012
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