CONFOCAL ENDOMICROSCOPY - CholangioFlexTM for Confocal CholangioscopyTM in ERCP
Confocal CholangioscopyTM: characterizing biliary strictures in real time
Cellvizio® probe-based Confocal Laser Endomicroscopy (pCLE) allows direct, real-time microscopic level visualization of the bile duct epithelium during an endoscopic retrograde cholangiopancreatography procedure (ERCP). This visualization of the bile duct in its finest details is a major step forward for ERCP, where traditional tools made it extremely difficult to obtain targeted histologic information to accurately characterize biliary strictures.
Watch the short movie below to see Cellvizio in action during ERCP.
Going beyond tissue sampling limitations
ERCP-directed tissue sampling methods have been shown to be associated with low sensitivity (40-50%) for the past 4 decades, even when several methods are combined and used by experts.
Endomicroscopic images of the bile duct showing different types of patterns: normal bile duct (left); abnormal vessels (center) and abnormal dark glands (right) indicative of cholangiocarcinoma, according to published work by Dr Meining, Klinikum Rechts der Isar, Munich, Germany.
The cellular information obtained by pCLE may be used during the procedure to target tissue sampling (brushings, biopsies or fine needle aspiration), after the procedure, to aid in documenting the clinical diagnosis and to add to the other clinically relevant parameters to assist in making treatment decisions on the spot.
A strong clinical validation with experts worldwide
Peer-reviewed publications of ERCP studies have shown that malignancies missed by conventional tissue sampling methods could be detected by the Cellvizio system, as proven by surgical specimen evaluation. In a first study at Klinikum Rechts der Isar in Munich, Meining and colleagues showed that pCLE increased the sensitivity of detection of cholangiocarcinoma to 83%
The Cellvizio ERCP Registry
From October 2008 to October 2009, 102 patients were enrolled in a prospective multi-centric, international registry called the "Cellvizio ERCP registry" at leading institutions in the US and Europe in order to develop image interpretation criteria and generate sensitivity outcomes data when characterizing indeterminate strictures of the bile and pancreatic ducts when Cellvizio is added to the standard ERCP.
Interim results of the Cellvizio ERCP registry were presented in 2 important oral presentations by Prof. Yang Chen (University of Colorado Hospital), principal investigator of the study, at the United European Gastroenterology Week 2009 (UEGW) 2009 conference in London and at the Digestive Disease Week 2010 (DDW) conference in New Orleans.
Results from another single-center study on more than 30 patients from Dr Giovannini and colleagues at the leading cancer center Institut Paoli-Calmettes in Marseilles, France, were also presented at DDW 2010 and confirmed a sensitivity of detection of cholangiocarcinoma of 83%, a major improvement over biopsies (53%).
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