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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 30, 2009
Last Update Posted: March 20, 2013
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.
Information provided by (Responsible Party):
Institut Paoli-Calmettes
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.

Condition Intervention
Pancreas Neoplasms Bile Duct Diseases Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor

Resource links provided by NLM:

Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: September 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: endomicroscopy
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.

Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

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

Marseille, France
Centre Hospitalier Princesse Grasse
Monaco, Monaco
Sponsors and Collaborators
Institut Paoli-Calmettes
Principal Investigator: Marc GIOVANNINI, MD Institut Paoli-Calmettes
  More Information

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00930410     History of Changes
Other Study ID Numbers: EMID/IPC 2008-001
First Submitted: June 27, 2009
First Posted: June 30, 2009
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Institut Paoli-Calmettes:
pancreas neoplasms
bile duct diseases
Cholangiopancreatography, Endoscopic Retrograde

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct Diseases
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases
Biliary Tract Neoplasms
Gastrointestinal Agents