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

Condition(s) targeted: Pancreas Neoplasms; Bile Duct Diseases

Intervention: Endoscopic Retrograde Cholangio-Pancreatography (ERCP) (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Institut Paoli-Calmettes

Official(s) and/or principal investigator(s):
Marc GIOVANNINI, MD, Principal Investigator, Affiliation: Institut Paoli-Calmettes

Overall contact:
Dominique GENRE, MD, Phone: (33)4 91 22 37 78, Email: bec@marseille.fnclcc.fr

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.

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

Study design: Diagnostic, Open Label, Single Group Assignment

Primary outcome: 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.

Secondary outcome:

Study of the concordance between optical and histological biopsy

Frequency and grade of adverse effects induced by the confocal endomicroscopy

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Dominique GENRE, MD, Phone: (33)4 91 22 37 78, Email: bec@marseille.fnclcc.fr

Institut PAOLI-CALMETTES, Marseille, France; Recruiting
Marc GIOVANNINI, MD

Official web site of the sponsor

Starting date: September 2008
Ending date: September 2011
Last updated: September 14, 2009