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Prospective RCT Highlights Technical Success and Performance of Cook Medical’s 20 Gauge ProCore FNB Needle

2019年06月25日 AM08:53
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BRISBANE, Australia

A newly published prospective, randomised controlled trial concluded that 20 gauge fine needle biopsy (FNB) needles consistently outperformed 25 gauge fine needle aspiration (FNA) needles in terms of histological yield and diagnostic accuracy, in pancreatic and non-pancreatic lesions. The data reported a 99% technical success rate for 20 gauge FNB needles (success was defined as the ability to obtain tissue from the target lesion) even though a ’significant number of lesions were sampled from an angulated endoscope position, including pancreatic head masses.’

‘We are pleased to see that results from this study demonstrate the consistent performance and flexibility of a 20 gauge FNB needle to yield better histological samples, including samples from difficult anatomical locations’, said Barry Slowey, vice president of Cook Medical’s Endoscopy clinical specialty. ‘This robust study provides much-needed data to analyse the efficacy of fine needle biopsy.’

The study is one of the largest prospective randomised trials comparing FNA and FNB sampling techniques ever conducted. 608 patients were enrolled from February 2015 to September 2016. The study compared the widely used 25 gauge EchoTip® Ultra FNA needle to the 20 gauge ProCore® FNB needle and was conducted in 13 endoscopic ultrasound (EUS) centres around the world in nine countries: Australia, Belgium, France, Italy, Israel, Japan, the Netherlands, Spain, and the United States.

Primarily focused on diagnostic accuracy, the study also assessed technical success, sample quality, and safety. It reported only two minor adverse events from the 302 patients randomly allocated to tissue sampling with FNB. The consistency of these results amongst the participating centres supports the general applicability of these findings.

EUS-guided FNB has become the primary method for evaluating suspicious lesions in the pancreas and surrounding tissue, as well as staging disease progression in digestive system cancers. Newer treatments and genetic characterisation of cancers require more tissue than is necessary for a simple positive or negative diagnosis obtained from FNA samples, but robust study data supporting FNB has been lacking in the past. Dr van Riet led the clinical investigation team for this study.

For more information about other endoscopy products, visit cookmedical.com/endoscopy.

van Riet PA, Larghi A, Attili F, et al. A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device. Gastrointestinal Endoscopy. 2019;89(2):329-339.

About Cook Medical

Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at cookmedical.com, and for the latest news, follow us on Twitter, Facebook and LinkedIn

View source version on businesswire.com: https://www.businesswire.com/news/home/20190624005767/en/

CONTACT

Emily Williams

Specialist, Corporate Communications, Cook Medical

+61 7 3434 6434 (office)

+61 417 762 894 (mobile)

Emily.williams@cookmedical.com

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