Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor (EMID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:
NCT00930410
First received: June 27, 2009
Last updated: March 19, 2013
Last verified: March 2013

June 27, 2009
March 19, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00930410 on ClinicalTrials.gov Archive Site
  • Study of the concordance between optical and histological biopsy [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Frequency and grade of adverse effects induced by the confocal endomicroscopy [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
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
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Monaco
 
NCT00930410
EMID/IPC 2008-001
No
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