Bile Duct Diseases, Pancreas Neoplasms
Conditions
Keywords
pancreas neoplasms, bile duct diseases, Cholangiopancreatography, Endoscopic Retrograde, ERCP
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
Interventions
Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 2 days |
Secondary
| Measure | Time frame |
|---|---|
| Study of the concordance between optical and histological biopsy | 2 days |
| Frequency and grade of adverse effects induced by the confocal endomicroscopy | 2 days |
Countries
France, Monaco
Outcome results
None listed