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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Pancreas Neoplasms, Bile Duct Diseases

Intervention / Treatment
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* Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: endomicroscopy<br>Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography | Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)<br>* Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreas neoplasms, bile duct diseases, Cholangiopancreatography, Endoscopic Retrograde, ERCP