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

Sponsor

Institut Paoli-Calmettes (Other)

Overall Status

Completed

CT.gov ID

NCT00930410

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreas Neoplasms Bile Duct Diseases	Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Study of the concordance between optical and histological biopsy [2 days]
Frequency and grade of adverse effects induced by the confocal endomicroscopy [2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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