Needle-based Confocal Laser Endomicroscopy (nCLE) : optical biopsy through EUSFNA needles, the new frontier.
Many patients with pancreatic cysts do not get a definitive diagnosis after an Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) procedure.
Although EUS-FNA is currently common practice, its sensitivity for cystic lesions diagnosis is usually low:
- Cytology has a sensitivity up to 40%(1)
- Carcino-Embryonic Antigen (CEA) improves sensitivity to 75%, potentially leaving many patients with malignant cysts(1)
Potential Cellvizio Advantages
Clinical studies have demonstrated that Cellvizio can facilitate(2-5):
- The differentiation between mucinous and non-mucinous pancreatic cysts during EUS-FNA procedures
- The quick identification of patients who need surgery
- The reduction of unnecessary diagnostic procedures
Watch a short movie on an AQ-Flex™ 19 procedure performed by Dr Marc Giovannini from Marseille, France.
Watch a Cellvizio Video of an IPMN cyst case with visible finger-like projections. Courtesy of Dr. Giovannini, IPC Marseilles.
1.Brugge W. at al., Diagnosis of Pancreatic Cystic Neoplasms: A Report of the Cooperative Pancreatic Cyst Study, Gastroenterology, 2004.
2. Waxman, I., Aslanian, H.R., Konda, V.J. Siddiqui, U.D., Wallace, M.B. First Assessment of Needle-based Confocal Laser Endomicroscopy (nCLE) During EUS-FNA Procedures of the Pancreas.GIE 2011
3. Giovannini, M. Monges, G.M., Caillol, F., Bories, E., Pesenti C. Feasibility of Intra Tumoral Confocal Microscopy Under EUS Guidance (EUS-CM). Poster at DDW 2011.
4. Konda VJ et al. An International, Multi-Center Trial on Needle-Based Confocal Laser Endomicroscopy (nCLE): Results From the In Vivo CLE Study in the Pancreas With Endosonography of Cystic Tumors (INSPECT) . Poster at DDW 2012
5. Nakai Y, Chang K, Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound, Through-the-Needle Confocal Laser-Induced Endomicroscopy and Cystoscopy Trial (DETECT Study). Oral presentation at DDW 2012
Cellvizio® systems are intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e. gastrointestinal, or respiratory, accessed through an endoscope or endoscopic accessories. The Cellvizio System is a regulated Medical Device, CE marked (Class IIa - NB : LNE/G-MED) and FDA cleared. Please consult labels and instructions for use.
These statements and the associated reference to specific clinical studies, are not intended to represent claims of safety or effectiveness for detecting or treating any specific condition or disease state. Rather this information is intended to provide useful reference to selected published literature describing physician experiences with the associated clinical uses. These statements have not been reviewed, cleared, or approved by the U.S. FDA. Any diagnostic assessment should always be made by the attending physician, based on the evaluation of all sources of clinical, endoscopic and other relevant information.