Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreas Neoplasms
- Sponsor
- Institut Paoli-Calmettes
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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'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.
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
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Study of the concordance between optical and histological biopsy(2 days)
- Frequency and grade of adverse effects induced by the confocal endomicroscopy(2 days)