Clinical Trial: Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Brief Summary: The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.
Detailed Summary:
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
Sponsor: Institut Paoli-Calmettes
Current Primary Outcome: 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. [ Time Frame: 2 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Study of the concordance between optical and histological biopsy [ Time Frame: 2 days ]
- Frequency and grade of adverse effects induced by the confocal endomicroscopy [ Time Frame: 2 days ]
Original Secondary Outcome: Same as current
Information By: Institut Paoli-Calmettes
Dates:
Date Received: June 27, 2009
Date Started: September 2008
Date Completion:
Last Updated: March 19, 2013
Last Verified: March 2013
