Back to resultsIntra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor (EMID)
Primary Purpose
Pancreas Neoplasms, Bile Duct Diseases
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreas Neoplasms focused on measuring pancreas neoplasms, bile duct diseases, Cholangiopancreatography, Endoscopic Retrograde, ERCP
Eligibility 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
Sites / Locations
- Institut PAOLI-CALMETTES
- Centre Hospitalier Princesse Grasse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
endomicroscopy
Arm Description
Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography
Outcomes
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.
Secondary Outcome Measures
Study of the concordance between optical and histological biopsy
Frequency and grade of adverse effects induced by the confocal endomicroscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00930410
Brief Title
Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Acronym
EMID
Official Title
Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Neoplasms, Bile Duct Diseases
Keywords
pancreas neoplasms, bile duct diseases, Cholangiopancreatography, Endoscopic Retrograde, ERCP
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endomicroscopy
Arm Type
Experimental
Arm Description
Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Intervention Description
Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Study of the concordance between optical and histological biopsy
Time Frame
2 days
Title
Frequency and grade of adverse effects induced by the confocal endomicroscopy
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc GIOVANNINI, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut PAOLI-CALMETTES
City
Marseille
Country
France
Facility Name
Centre Hospitalier Princesse Grasse
City
Monaco
Country
Monaco
12. IPD Sharing Statement
Links:
URL
http://www.institutpaolicalmettes.fr/
Description
Official web site of the sponsor
Learn more about this trial
Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor
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