Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Information source: Institut Paoli-Calmettes
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreas Neoplasms; Bile Duct Diseases
Intervention: Endoscopic Retrograde Cholangio-Pancreatography (ERCP) (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Institut Paoli-Calmettes Official(s) and/or principal investigator(s): Marc GIOVANNINI, MD, Principal Investigator, Affiliation: Institut Paoli-Calmettes
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.
Clinical Details
Official title: Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: 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.
Secondary outcome: Study of the concordance between optical and histological biopsyFrequency and grade of adverse effects induced by the confocal endomicroscopy
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Institut PAOLI-CALMETTES, Marseille, France
Centre Hospitalier Princesse Grasse, Monaco, Monaco
Additional Information
Official web site of the sponsor
Starting date: September 2008
Last updated: March 19, 2013
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