Status:

COMPLETED

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

Lead Sponsor:

Institut Paoli-Calmettes

Conditions:

Pancreas Neoplasms

Bile Duct Diseases

Eligibility:

All Genders

18+ years

Phase:

NA

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'...

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 Cholan...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    May 1 2012

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT00930410

    Start Date

    September 1 2008

    End Date

    May 1 2012

    Last Update

    March 20 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Institut PAOLI-CALMETTES

    Marseille, France

    2

    Centre Hospitalier Princesse Grasse

    Monaco, Monaco