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


N/A
18 Years
N/A
Not Enrolling
Both
Pancreas Neoplasms, Bile Duct Diseases

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

2 days

Safety Issue:

No

Principal Investigator

Marc GIOVANNINI, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

EMID/IPC 2008-001

NCT ID:

NCT00930410

Start Date:

September 2008

Completion Date:

May 2012

Related Keywords:

  • Pancreas Neoplasms
  • Bile Duct Diseases
  • pancreas neoplasms
  • bile duct diseases
  • Cholangiopancreatography, Endoscopic Retrograde
  • ERCP
  • Bile Duct Diseases
  • Bile Duct Neoplasms
  • Neoplasms
  • Pancreatic Neoplasms

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