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. Identifier: NCT00930410
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):
Institut Paoli-Calmettes

June 27, 2009
June 30, 2009
March 20, 2013
September 2008
May 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00930410 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
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.

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
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Pancreas Neoplasms
  • Bile Duct Diseases
Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.
Experimental: endomicroscopy
Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography
Intervention: Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged from 18 to older
  • Patient with an inflammatory or tumoral stenosis of bile duct or a solid or cystic tumor in the pancreas with a dilatation of the principal pancreatic canal.
  • Signed consent

Non inclusion Criteria:

  • Patient who have no indication for an ERCP
  • Allergy to fluorescein
  • Allergic rhinitis, asthma, eczema
  • Pregnancy, breast feeding
  • Patients with dialysis
  • Patient with severe heart failure
  • Patient with cirrhosis
  • Hemostasis failure which can induce difficulties or contraindication for the biopsy during the conventional endoscopy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
France,   Monaco
EMID/IPC 2008-001
Not Provided
Not Provided
Institut Paoli-Calmettes
Institut Paoli-Calmettes
Not Provided
Principal Investigator: Marc GIOVANNINI, MD Institut Paoli-Calmettes
Institut Paoli-Calmettes
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP