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

Bile Duct Diseases Clinical Trial

— EMID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930410
• Other study ID #: EMID/IPC 2008-001
• Status: Completed
• Phase: N/A
• First received: June 27, 2009
• Last updated: March 19, 2013
• Start date: September 2008
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bile Duct Diseases
• Bile Duct Neoplasms
• Pancreas Neoplasms
• Pancreatic Neoplasms

Intervention

Procedure:
• Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.

Locations

Country	Name	City	State
France	Institut PAOLI-CALMETTES	Marseille
Monaco	Centre Hospitalier Princesse Grasse	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Study of the concordance between optical and histological biopsy		2 days	No
Secondary	Frequency and grade of adverse effects induced by the confocal endomicroscopy		2 days	Yes

External Links

•   Official web site of the sponsor