title: Core biopsy needle versus standard aspiration needle for endoscopic ultrasound-guided sampling of solid pancreatic masses: a randomized parallel-group study.
abstract: OBJECTIVE
  An endoscopic ultrasound (EUS)-guided fine needle biopsy (EUS-FNB) device using a core biopsy needle was developed to improve diagnostic accuracy by simultaneously obtaining cytological aspirates and histological core samples. We prospectively compared the diagnostic accuracy of EUS-FNB with standard EUS-guided fine needle aspiration (EUS-FNA) in patients with solid pancreatic masses.
  
  
  METHODS
  Between January 2012 and May 2013, consecutive patients with solid pancreatic masses were prospectively enrolled and randomized to undergo EUS-FNB using a core biopsy needle or EUS-FNA using a standard aspiration needle at a single tertiary center. The specimen was analyzed by onsite cytology, Papanicolaou-stain cytology, and histology. The main outcome measure was diagnostic accuracy for malignancy. The secondary outcome measures were: the median number of passes required to establish a diagnosis, the proportion of patients in whom the diagnosis was established with each pass, and complication rates.
  
  
  RESULTS
  The overall accuracy of combining onsite cytology with Papanicolaou-stain cytology and histology was not significantly different for the FNB (n = 58) and FNA (n = 58) groups (98.3 % [95 %CI 94.9 % - 100 %] vs. 94.8 % [95 %CI 91.9 % - 100 %]; P = 0.671). Compared with FNA, FNB required a significantly lower median number of needle passes to establish a diagnosis (1.0 vs. 2.0; P < 0.001). On subgroup analysis of 111 patients with malignant lesions, the proportion of patients in whom malignancy was diagnosed on the first pass was significantly greater in the FNB group (72.7 % vs. 37.5 %; P < 0.001).
  
  
  CONCLUSIONS
  The overall accuracy of FNB and FNA in patients with solid pancreatic masses was comparable; however, fewer passes were required to establish the diagnosis of malignancy using FNB.This study was registered on the UMIN Clinical Trial Registry (UMIN000014057).
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
authors.forename: Yun Nah
authors.initials: YN
authors.lastname: Lee
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
authors.forename: Jong Ho
authors.initials: JH
authors.lastname: Moon
authors.affiliation: Department of Pathology, SoonChunHyang University School of Medicine, Bucheon, Korea.
authors.forename: Hee Kyung
authors.initials: HK
authors.lastname: Kim
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
authors.forename: Hyun Jong
authors.initials: HJ
authors.lastname: Choi
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
authors.forename: Moon Han
authors.initials: MH
authors.lastname: Choi
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
authors.forename: Dong Choon
authors.initials: DC
authors.lastname: Kim
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
authors.forename: Tae Hoon
authors.initials: TH
authors.lastname: Lee
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
authors.forename: Sang-Woo
authors.initials: SW
authors.lastname: Cha
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
authors.forename: Young Deok
authors.initials: YD
authors.lastname: Cho
authors.affiliation: Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, Korea.
authors.forename: Sang-Heum
authors.initials: SH
authors.lastname: Park
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062005:Biopsy, Large-Core Needle / Q000295:instrumentation; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000295:instrumentation; D004867:Equipment Design; D005500:Follow-Up Studies; D009339:Needles; D010190:Pancreatic Neoplasms / Q000175:diagnosis; D011446:Prospective Studies