PARIS, October 21, 2015 /PRNewswire/ --
Mauna Kea Technologies (Euronext: MKEA, FR0010609263, PEA-PME eligible), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced that the peer-reviewed journal Surgical Endoscopy has released a new article highlighting the advantages of needle-based confocal laser endomicroscopy (nCLE) for characterization of different types of pancreatic cysts.
The group of endoscopists-investigators of CONTACT-1 study and their pathologists have retrospectively defined new criteria to classify malignant and pseudocysts for the first time and confirmed the characteristics of the benign serous cysts published earlier this year. This retrospective analysis included 33 patients followed 1-year and focused on the diagnosis of solitary pancreatic cystic lesions using nCLE. Independent endoscopists have validated these criteria with a substantial intra-observer agreement (kappa = 0.72).
Those results show a strong sensitivity and specificity for the 3 categories of cysts (respectively 69% and 100% for serous cystadenomas, 91% and 95% for mucinous cysts and 43% and 100% for pseudocysts).
According to the authors: “The development of nCLE techniques for the diagnosis of pancreatic cysts, and in particular the high specificity observed in our current dataset, can have important implications for patient management. In cases where surgery is necessary (i.e., for cysts with malignant potential, primarily MCN), it should be to achieve this with the shortest delay.”
Doctor Bertrand Napoleon, Hospital Jean Mermoz, Lyon, France underlines the importance of identifying benign cysts with such a level of confidence: “If the cyst is considered without malignant potential (i.e., serous cysts), obtaining a specific diagnosis at an early stage is key; it could avoid unnecessary/repeated investigations inducing additional costs and delay, and unnecessary surgery, associated with high morbidity and mortality”.
“These additional results from our pilot study CONTACT-1 confirm the potential benefits of Cellvizio in the management of patients with pancreatic cystic lesions by rapidly and accurately identifying the nature of the lesions avoiding commonly observed inappropriate treatments for numerous patients each year. Mauna Kea Technologies remains on track to complete enrollment in its 200-patient sponsored-study CONTACT 2 by the end of the year. We look forward to providing an update on our progress with this important trial in the near future.” said Sacha Loiseau, founder and CEO of Mauna Kea Technologies.
Publication reference: Napoleon B, Lemaistre AI, Pujol B, Caillol F, Lucidarme D, Bourdariat R, Morellon-Mialhe B, Fumex F, Lefort C, Lepilliez V, Palazzo L, Monges G, Poizat F, Giovannini M. In vivo characterization of pancreatic cystic lesions by needle-based confocal laser endomicroscopy (nCLE): proposition of a comprehensive nCLE classification confirmed by an external retrospective evaluation. Surg Endosc. 2015 Oct 1.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company focused on protecting patients’ lives while enabling physicians and surgeons to make better decisions thanks to direct visualization at the cellular level. The Company’s flagship product, Cellvizio, has received clearance to sell a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico.
For more information on Mauna Kea Technologies, visit http://www.maunakeatech.com
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SOURCE Mauna Kea Technologies
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