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

Sponsor:	Institut Paoli-Calmettes
Information provided by:	Institut Paoli-Calmettes
ClinicalTrials.gov Identifier:	NCT00930410

Purpose

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	Intervention
Pancreas Neoplasms Bile Duct Diseases	Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor

Resource links provided by NLM:

MedlinePlus related topics: Bile Duct Diseases Cancer Endoscopy

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Institut Paoli-Calmettes:

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. [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Study of the concordance between optical and histological biopsy [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Frequency and grade of adverse effects induced by the confocal endomicroscopy [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
endomicroscopy: Experimental 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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930410

Contacts

Contact: Dominique GENRE, MD	(33)4 91 22 37 78	bec@marseille.fnclcc.fr
Contact: Agnès BOYER CHAMMARD, MD	(33)4 91 22 37 78	bec@marseille.fnclcc.fr

Locations

France
Institut PAOLI-CALMETTES	Recruiting
Marseille, France
Contact: Marc GIOVANNINI, MD

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

Principal Investigator:

Marc GIOVANNINI, MD

Institut Paoli-Calmettes

More Information

Additional Information:

Official web site of the sponsor This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Institut Paoli-Calmettes ( Marc GIOVANNINI )
Study ID Numbers:	EMID/IPC 2008-001
Study First Received:	June 27, 2009
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00930410 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Paoli-Calmettes:

pancreas neoplasms
bile duct diseases
Cholangiopancreatography, Endoscopic Retrograde
ERCP

Additional relevant MeSH terms:

Biliary Tract Neoplasms
Digestive System Neoplasms
Pancreatic Neoplasms
Gastrointestinal Agents
Endocrine System Diseases
Pancrelipase
Pharmacologic Actions
Neoplasms

Digestive System Diseases
Neoplasms by Site
Bile Duct Diseases
Therapeutic Uses
Biliary Tract Diseases
Pancreatic Diseases
Bile Duct Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010