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

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ClinicalTrials.gov Identifier: NCT00930410
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : March 20, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Pancreas Neoplasms Bile Duct Diseases Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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 ]

Eligibility Criteria

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
Criteria

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


Locations
France
Institut PAOLI-CALMETTES
Marseille, France
Monaco
Centre Hospitalier Princesse Grasse
Monaco, Monaco
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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 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
ERCP

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