title: Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study.
abstract: BACKGROUND
  There are very few available data on the novel SharkCore™ needles for EUS-FNB.
  
  
  OBJECTIVE
  Comparison of the performance of the SharkCore™ needles with the standard EUS-FNA needles for the diagnosis of solid upper GI masses.
  
  
  METHODS
  Single-center, retrospective cohort study in an academic tertiary referral hospital. Patients were matched 1:1 for the site of the lesion and the presence or absence of rapid on-site evaluation (ROSE).
  
  
  RESULTS
  A total of 102 patients were included. There was no statistically significant difference in the mean number of passes (3.3 ± 1.3 versus 3.4 ± 1.5; p = .89). Similar results were observed at the subgroup with ROSE (4.3 ± 1.3 versus 3.7 ± 1.5; p = .26). More histological specimens were obtained with the SharkCore™ needles compared to standard needles (59 versus 5%; p < .001). Diagnostic test characteristics were not significantly different (sensitivity: 91.5 versus 85.7; specificity: 100 versus 100%; accuracy: 92.2 versus 85.4% for SharkCore™ versus standard needles, p > .05 in all cases). At multivariable analysis, there was no statistically significant difference in the mean number of passes in all patients (p = .23) and in the ROSE subgroup (p = .66). However, the SharkCore™ needle obtained significantly more histological material than the standard needle (odds ratio 66; 95% confidence interval: 11.8, 375.8, p < .001). There was no significant difference in complication rates (p = .5).
  
  
  CONCLUSIONS
  Retrospective study, single-center.
  
  
  CONCLUSIONS
  The SharkCore needles were similar to standard FNA needles in terms of the number of passes to reach diagnosis, but obtained significantly more histological specimen.
authors.affiliation: a Clinical and Translational Epidemiology Unit, Division of Gastroenterology , Massachusetts General Hospital and Harvard Medical School , Boston , MA , USA.
authors.forename: Manol
authors.initials: M
authors.lastname: Jovani
authors.affiliation: b Division of Gastroenterology, Hepatology and Endoscopy , Brigham and Women's Hospital and Harvard Medical School , Boston , MA , USA.
authors.forename: Wasif M
authors.initials: WM
authors.lastname: Abidi
authors.affiliation: b Division of Gastroenterology, Hepatology and Endoscopy , Brigham and Women's Hospital and Harvard Medical School , Boston , MA , USA.
authors.forename: Linda S
authors.initials: LS
authors.lastname: Lee
mesh_terms: D000368:Aged; D003937:Diagnosis, Differential; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009339:Needles / Q000145:classification*; D009369:Neoplasms / Q000175:diagnosis / Q000473:pathology*; D012044:Regression Analysis; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D062606:Tertiary Care Centers; D041742:Upper Gastrointestinal Tract / Q000473:pathology*
keywords: 22 gauge; 25 gauge; Endoscopic ultrasound; SharkCore; fine needle aspiration; fine needle biopsy; histology; pancreas; solid masses