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

Institut Paoli-Calmettes

Status

Completed

Conditions

Bile Duct Diseases

Pancreas Neoplasms

Treatments

Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Study type

Interventional

Funder types

Other

Identifiers

NCT00930410

EMID/IPC 2008-001

Details and patient eligibility

About

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.

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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