Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor (EMID)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00930410|
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : March 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Neoplasms Bile Duct Diseases||Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)||Not Applicable|
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).
- Compare the result of this "optical biopsy" to a conventional biopsy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography
Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930410
|Centre Hospitalier Princesse Grasse|
|Principal Investigator:||Marc GIOVANNINI, MD||Institut Paoli-Calmettes|