title: Randomized Noninferiority Trial Comparing Diagnostic Yield of Cytopathologist-guided versus 7 passes for EUS-FNA of Pancreatic Masses.
abstract: To improve diagnostic yield of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) in solid pancreatic lesions, on-site cytology review has been recommended. Because this is not widely available throughout the world, the aim of this study was to compare the diagnostic yield of EUS-FNA performed with rapid on-site evaluation (ROSE) versus 7 FNA passes without ROSE in pancreatic masses.
  
  
  
  In this multicenter randomized noninferiority trial, patients were randomized to ROSE versus 7 passes into a solid pancreatic mass. On the basis of the absolute difference in diagnostic yield with 7 passes versus cytopathologist-guidance, the noninferiority margin for the difference in diagnostic yield was defined as -15%. Definite diagnosis was defined to include positive for malignancy, neoplastic cells present, and negative for malignancy.
  
  
  
  A total of 142 patients were randomized with 73 in the cytopathologist arm and 69 in the 7 passes arm. Diagnostic yield for definite diagnosis was 78.3% with 7 passes and 78.1% with cytopathology guidance. With an absolute difference 0.2%, 95% CI -14.4 to 14.6, performing 7 passes was noninferior to cytopathologist-guided EUS-FNA. There was no significant difference in complications or time to perform FNA. A median of 5 passes were performed with ROSE. The median charge with onsite cytopathology was significantly greater than performing 7 passes [$1058 (958, 1445) versus $375 (275, 460), p<0.001].
  
  
  
  The diagnostic yield for performing 7 passes during EUS-FNA into solid pancreatic masses is noninferior with lower charge compared to cytopathologist-guidance. This article is protected by copyright. All rights reserved.
authors.affiliation: Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
authors.forename: Linda S
authors.initials: LS
authors.lastname: Lee
authors.affiliation: Borland-Groover Clinic, Jacksonville, FL.
authors.forename: Jose
authors.initials: J
authors.lastname: Nieto
authors.affiliation: UCLA Medical Center, Digestive Diseases, Los Angeles, CA.
authors.forename: Rabindra R
authors.initials: RR
authors.lastname: Watson
authors.affiliation: Gastroenterology Consultants of Greater Lowell, North Chelmsford, MA.
authors.forename: Allen L
authors.initials: AL
authors.lastname: Hwang
authors.affiliation: UCLA Medical Center, Digestive Diseases, Los Angeles, CA.
authors.forename: Venkatara R
authors.initials: VR
authors.lastname: Muthusamy
authors.affiliation: Borland-Groover Clinic, Jacksonville, FL.
authors.forename: Laura
authors.initials: L
authors.lastname: Walter
authors.affiliation: Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
authors.forename: Kunal
authors.initials: K
authors.lastname: Jajoo
authors.affiliation: Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
authors.forename: Marvin K
authors.initials: MK
authors.lastname: Ryou
authors.affiliation: Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
authors.forename: John R
authors.initials: JR
authors.lastname: Saltzman
authors.affiliation: Division of Gastroenterology and Digestive Disease Center, University of Washington Medical Center, Seattle, WA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Saunders
authors.affiliation: Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
authors.forename: Shadeah
authors.initials: S
authors.lastname: Suleiman
authors.affiliation: Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
authors.forename: Vivek
authors.initials: V
authors.lastname: Kadiyala
keywords: Cytology; EUS-FNA; diagnosis; pancreas; randomized trial