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

Not Applicable

Completed

• Conditions: Pancreas Neoplasms; Bile Duct Diseases
• Interventions: Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

• Registration Number: NCT00930410
• Lead Sponsor: Institut Paoli-Calmettes

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

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-06-27
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endomicroscopy	Endoscopic Retrograde Cholangio-Pancreatography (ERCP)	Utilisation of an intra-ductal confocal endomicroscopy during the endoscopic Retrograde Cholangio-Pancreatography

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Study of the concordance between optical and histological biopsy	2 days
Frequency and grade of adverse effects induced by the confocal endomicroscopy	2 days

Trial Locations

Locations (2)

Institut PAOLI-CALMETTES; 🇫🇷 Marseille, France

Centre Hospitalier Princesse Grasse; 🇲🇨 Monaco, Monaco