Intra-ductal Confocal Endomicroscopy For Characterization Of Pancreas And Bile Duct Tumor

Study Overview

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

Pancreas Neoplasms
Bile Duct Diseases

PROCEDURE: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

EMID/IPC 2008-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-06-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-03-19
First Submitted that Met QC Criteria 2009-06-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-03-20
First Posted (ESTIMATED) 2009-06-30	Results First Posted N/A	Last Verified 2013-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: endomicroscopy Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography	PROCEDURE: Endoscopic Retrograde Cholangio-Pancreatography (ERCP) Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: endomicroscopy

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

PROCEDURE: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Marc GIOVANNINI, MD, Institut Paoli-Calmettes

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record