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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

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.

Condition or disease Intervention/treatment Phase
Pancreas Neoplasms Bile Duct Diseases Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
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
Study Start Date : September 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. Study of the concordance between optical and histological biopsy [ Time Frame: 2 days ]
  2. Frequency and grade of adverse effects induced by the confocal endomicroscopy [ Time Frame: 2 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00930410

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Marseille, France
Centre Hospitalier Princesse Grasse
Monaco, Monaco
Sponsors and Collaborators
Institut Paoli-Calmettes
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Principal Investigator: Marc GIOVANNINI, MD Institut Paoli-Calmettes
Additional Information:
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Responsible Party: Institut Paoli-Calmettes Identifier: NCT00930410    
Other Study ID Numbers: EMID/IPC 2008-001
First Posted: June 30, 2009    Key Record Dates
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:
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Pancreatic Neoplasms
Bile Duct Neoplasms
Bile Duct Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases
Biliary Tract Neoplasms