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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-05-31

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.

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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

Conditions

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Pancreas Neoplasms Bile Duct Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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endomicroscopy

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

Group Type EXPERIMENTAL

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Intervention Type PROCEDURE

Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.

Interventions

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Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.

Intervention Type PROCEDURE

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No