NCT00930410

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreas Neoplasms
• Bile Duct Diseases

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Retrograde Cholangio-Pancreatography (ERCP)	Utilisation of the Intra-ductal confocal endomicroscopy to obtain any exploitable image for the anatomopathology.

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-06-30
• Last updated: 2013-03-20

Locations

2 sites across 2 countries: France, Monaco