title: Accuracy and inter-observer agreement of the Procore™ 25 gauge needle for endoscopic ultrasound-guided tissue core biopsy.
abstract: BACKGROUND
  Scanty data on the performance of the new 25-gauge Procore™ biopsy needle are available.
  
  
  METHODS
  Consecutive patients who underwent endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) using the 25G Procore™ were retrospectively retrieved. All samples were independently reviewed by 3 pathologists for the following: histological, cytological or no specimen, neoplasia, diagnostic or non-diagnostic. Diagnostic accuracy and inter-rater concordance among pathologists were calculated.
  
  
  RESULTS
  94 patients underwent EUS-FNB of 101 sites (69 solid masses, 25 lymph nodes, 5 wall thickening). Forty-one biopsies (40.5%) were classified as histological samples by at least two pathologists, 29 as cytological (28.7%), 31 had no sample (30.7%). Good and almost perfect agreements among pathologists in defining cytological vs. histological samples (k 0.82; 95% CI: 0.74-0.90), diagnostic vs. non-diagnostic (k 0.95; 95% CI: 0.85-1.00) and neoplastic vs. non-neoplastic (k 0.94; 95% CI: 0.83-1.00). According to consensus rating, 61 cases were diagnostic samples (60.4%). Histological samples were more likely to lead to a correct diagnosis (OR, 4.1; 95% P=0.027), while neoplastic lesions were less likely to be correctly classified than benign (OR, 0.11; P=0.04).
  
  
  CONCLUSIONS
  EUS-FNB with the Procore™ 25G needle provided samples for histological examination in only 40% of the cases, with 31% of inadequate specimens, despite excellent results in term of inter-observer variability.
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: Fabia
authors.initials: F
authors.lastname: Attili
authors.affiliation: Department of Pathology, Catholic University, Rome, Italy.
authors.forename: Gianluigi
authors.initials: G
authors.lastname: Petrone
authors.affiliation: Department of Pathology, University Hospital of Santiago de Compostela, Spain.
authors.forename: Ihab
authors.initials: I
authors.lastname: Abdulkader
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: Loredana
authors.initials: L
authors.lastname: Correale
authors.affiliation: Department of Pathology, Catholic University, Rome, Italy.
authors.forename: Frediano
authors.initials: F
authors.lastname: Inzani
authors.affiliation: Gastroenterology Department, Foundation for Research in Digestive Diseases (FIENAD), University Hospital of Santiago de Compostela, Spain.
authors.forename: Julio
authors.initials: J
authors.lastname: Iglesias-Garcia
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: Cesare
authors.initials: C
authors.lastname: Hassan
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: Santiago
authors.initials: S
authors.lastname: Andrade Zurita
authors.affiliation: Department of Pathology, Catholic University, Rome, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Rindi
authors.affiliation: Gastroenterology Department, Foundation for Research in Digestive Diseases (FIENAD), University Hospital of Santiago de Compostela, Spain.
authors.forename: J Enrique
authors.initials: JE
authors.lastname: Dominguez-Muñoz
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
authors.affiliation: Digestive Endoscopy Unit, Catholic University, Rome, Italy. Electronic address: alberto.larghi@yahoo.it.
authors.forename: Alberto
authors.initials: A
authors.lastname: Larghi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000473:pathology; D062005:Biopsy, Large-Core Needle; D002277:Carcinoma / Q000473:pathology*; D018269:Carcinoma, Endometrioid / Q000473:pathology; D006528:Carcinoma, Hepatocellular / Q000473:pathology; D021441:Carcinoma, Pancreatic Ductal / Q000473:pathology; D004067:Digestive System Neoplasms / Q000473:pathology*; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000473:pathology; D008175:Lung Neoplasms / Q000473:pathology*; D008198:Lymph Nodes / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D018241:Neuroectodermal Tumors, Primitive, Peripheral / Q000473:pathology*; D015588:Observer Variation; D010190:Pancreatic Neoplasms / Q000473:pathology; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013274:Stomach Neoplasms / Q000473:pathology; D047368:Tumor Burden
keywords: EUS-FNA; EUS-FNB; Inter-observer agreement; Tissue acquisition