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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
History of Changes
  Purpose

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: Open Label
Primary Purpose: Diagnostic
Official Title: Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Official web site of the sponsor  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT00930410     History of Changes
Other Study ID Numbers: EMID/IPC 2008-001
Study First Received: June 27, 2009
Last Updated: March 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 23, 2013