March 28, 2017
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Cellvizio accurately diagnoses pancreatic cysts

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Endoscopic ultrasound-guided needle-based confocal laser endomicroscopy using the Cellvizio platform characterized pancreatic cysts with high accuracy and “near-perfect” inter- and intraobserver agreement in recent study.

Cellvizio (Mauna Kea Technologies) is a multidisciplinary confocal laser endomicroscopy (CLE) platform that provides real-time “virtual histology,” and needle-based CLE (nCLE) is a developing strategy for pre-surgical evaluation of pancreatic cystic lesions.

Somashekar G. Krishna, MD, MPH

Somashekar G. Krishna

Somashekar G. Krishna, MD, MPH, of the division of gastroenterology, hepatology and nutrition at the Ohio State University Wexner Medical Center, and colleagues evaluated the performance of EUS-guided nCLE for differentiating mucinous and benign non-mucinous pancreatic cystic lesions.

They retrospectively analyzed the Ohio State University Medical Center’s EUS database to identify all patients who underwent EUS-guided nCLE for the evaluation of pancreatic cystic lesions between 2013 and 2016. Then, six international nCLE-experienced endosonographers who were masked to all clinical data reviewed videos of pancreatic cystic lesions from 23 patients with surgically confirmed diagnoses and six patients with clinically confirmed diagnoses (16 mucinous and 13 non-mucinous lesions). Two weeks later, they reviewed the same images in a different sequence.

EUS-guided nCLE diagnosed mucinous pancreatic cystic lesions with 95% sensitivity, 94% specificity and 95% accuracy, and with “almost perfect” interobserver agreement and intraobserver reliability. Further, the technique diagnosed non-mucinous lesions with 99% sensitivity, 98% specificity and 98% accuracy, and also with “almost perfect” interobserver agreement and intraobserver reliability.

“This study demonstrates that EUS-nCLE provides in vivo diagnostic imaging of large [pancreatic cystic lesions] with a high diagnostic accuracy,” Krishna and colleagues concluded.

Additionally, the investigators identified “novel vascular patterns and suggested a reasonable classification of nCLE patterns of [pancreatic cystic lesions] facilitating their diagnosis,” they wrote, adding that their findings should be confirmed in larger multicenter studies.

“The results from this well-designed independent, international study, confirm the unmatched level of sensitivity and specificity for characterizing cystic lesions of the pancreas,” Sacha Loiseau, PhD, founder and CEO of Mauna Kea Technologies, said in a press release. “Millions of Americans have a pancreatic lesion and tens of thousands will undergo an unnecessary interventional procedure, including surgeries. These results confirm that, as we have seen with other large studies, a majority of these procedures could be avoided with a single Cellvizio procedure performed during an [EUS] examination.” – by Adam Leitenberger

Disclosures: The researchers report no relevant financial disclosures. Loiseau is employed by Mauna Kea Technologies.