Prospective RCT Highlights Technical Success and Performance of Cook Medical’s 20 gage ProCore FNB Needle
BLOOMINGTON, Ind.--(BUSINESS WIRE)-- A newly published prospective, randomized controlled trial concluded that 20 gage fine needle biopsy (FNB) needles consistently outperformed 25 gage fine needle aspiration (FNA) needles in terms of histological yield and diagnostic accuracy, in pancreatic and non-pancreatic gastrointestinal lesions. The data reported a 99% technical success rate for 20 gage 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 gage 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 analyze the efficacy of fine needle biopsy.”
The study is one of the largest prospective randomized 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 gage EchoTip® Ultra FNA needle to the 20 gage ProCore® FNB needle and was conducted in 13 endoscopic ultrasound (EUS) centers 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 among the participating centers 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 characterization 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.
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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.
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Source: Cook Medical