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

Official Title: “Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor”

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.

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

Intervention(s) in this Clinical Trial

• Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
  • Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: endomicroscopy
  • Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography

Primary 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
    Safety Issue?: No

Secondary Measures

• Study of the concordance between optical and histological biopsy
  • Time Frame: 2 days
    Safety Issue?: No
• Frequency and grade of adverse effects induced by the confocal endomicroscopy
  • Time Frame: 2 days
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Institut Paoli-Calmettes Other

Overall Clinical Trial Officials and Contacts

Marc GIOVANNINI, MD Principal Investigator Institut Paoli-Calmettes  

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930410

Study ID Number: EMID/IPC 2008-001

ClinicalTrials.gov Identifier: NCT00930410

Health Authority: France: Afssaps - French Health Products Safety Agency

Official web site of the sponsor