Biopsy Needle Provides Advanced Accuracy in Diagnosing Cancers of GI Tract

Needle retrieves histological samples from hard-to-reach tissue with fewer needle passes

BLOOMINGTON, Ind.--(BUSINESS WIRE)--Results from a multicenter European study¹ suggest that a new, large-core biopsy needle designed for use with an endoscopic ultrasound (EUS) scope may help to overcome limitations of current EUS methods for biopsies of lesions in the gastrointestinal (GI) tract and surrounding tissue. The study, presented in abstract form at the 2011 Digestive Disease Week conference, indicated that Cook Medical’s 19-gauge EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle can aid pathologists in diagnosing multiple types of cancers in a variety of target tissues with a high degree of accuracy.

“Cook Medical’s EchoTip Ultra® line of needles are the world’s leading endoscopic ultrasound needles and are widely used for obtaining cytological and histological samples by EUS”

“…Performing an EUS-guided biopsy with the new histology needle was feasible and safe for histopathology diagnosis of intraintestinal and extraintestinal mass lesions in this consecutive series of patients,” said the study in its conclusion. “It offers the possibility of obtaining a core sample for histological evaluation in the majority of cases, with an overall diagnostic accuracy of over 85 percent.”

Dr. Julio Iglesias-Garcia, the lead investigator of the study and associate faculty member at the University Hospital of Santiago de Compostela, Spain, Gastroenterology department said, “the 19-gauge EchoTip ProCore needle by Cook Medical improves what is already an incredibly valuable diagnostic tool. The needle allows pathologists to sample a variety of lesions without compromising diagnostic accuracy, which could lead to earlier detection of GI malignancies.”

EUS is an established procedure for diagnosing GI cancers and determining the stage of their development. Most often, a very fine needle is used—but fine-needle aspiration (FNA) can have limited yield and sensitivity for certain kinds of tumors or in some anatomical locations and only procures a cytological sample.

The EchoTip ProCore needles circumvent this limitation by obtaining intact tissue samples², allowing for a histological diagnosis rather than conventional cytological diagnosis based on individual cells. In addition to this advantage, the needles are designed to access difficult-to-reach tissue in areas of the GI tract such as the pancreatic head.

In the five-center study to be published in Gastrointestinal Endoscopy, the 19-gauge EchoTip ProCore retrieved adequate histological tissue samples in 89.5 percent of cases, and subsequent diagnosis proved accurate in more than 85 percent of total cases. The overall accuracy for detecting malignancy in EchoTip ProCore samples was greater than 92 percent. Moreover, 78 percent of the samples were collected with just one pass of the needle; in FNA, the recommended number of passes can be as high as seven. Researchers studied 109 patients with 114 intestinal lesions and/or peri-intestinal lymph nodes.

“Cook Medical’s EchoTip Ultra^® line of needles are the world’s leading endoscopic ultrasound needles and are widely used for obtaining cytological and histological samples by EUS,” said Barry Slowey, global business unit leader for Cook Medical’s Endoscopy division, the industry’s only full-line supplier of endoscopic devices. “We’re proud to advance the technology in obtaining histological yields with the new EchoTip ProCore and further aid physicians in the early diagnosis and treatment of GI disorders.”

About Cook Medical

Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologic grafts to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation. For more information, visit www.cookmedical.com. Follow Cook Medical on Twitter @cookmedicalpr and @cookgastro.

Dr. Iglesias-Garcia is a paid consultant for Cook Medical.

¹ Iglesias-Garcia J, Poley JW, Larghi A, et al. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011. Doi:10.1016/j.gie.2011.01.053

² Data on file at Cook.