title: Histologic diagnosis of pancreatic masses using 25-gauge endoscopic ultrasound needles with and without a core trap: a multicenter randomized trial.
abstract: OBJECTIVE
  Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) with 25-gauge needles yields small volume samples that are mainly processed for cytology. Using 25-gauge needles with a core trap may overcome this limitation. This trial compared 25-gauge needles with and without a core trap in terms of their ability to obtain histologic samples from solid pancreatic masses.
  
  
  METHODS
  Consecutive patients with solid pancreatic masses who presented to eight Japanese referral centers for EUS-FNA in April - September 2013 were randomized to undergo sampling with a 25-gauge needle with a core trap (ProCore) or a standard 25-gauge needle. Tissue samples were fixed in formalin and processed for histologic evaluation. For the purpose of this study only samples obtained with the first needle pass were used for comparison of: (i) accuracy for the diagnosis of malignancy, (ii) rate of samples with preserved tissue architecture adequate for histologic evaluation, and (iii) sample cellularity.
  
  
  RESULTS
  A total of 214 patients were enrolled. Compared to the first pass with a standard needle (n = 108), the first pass with the ProCore needle (n = 106) provided samples that were more often adequate for histologic evaluation (81.1 % vs. 69.4 %; P = 0.048) and had superior cellularity (rich/moderate/poor, 36 %/27 %/37 % vs. 19 %/26 %/55 %; P = 0.003). There were no significant differences between the two needles in sensitivity (75.6 % vs. 69.0 %, P = 0.337) and accuracy (79.2 % vs. 75.9 %, P = 0.561) for the diagnosis of malignancy.
  
  
  CONCLUSIONS
  In patients with solid pancreatic masses, a 25-gauge EUS-FNA needle with a core trap provides histologic samples of better quality than a standard 25-gauge needle. There was no difference in accuracy for the diagnosis of malignancy between the needles.
  
  
  BACKGROUND
  UMIN000010021.
authors.affiliation: Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Kamata
authors.affiliation: Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Kitano
authors.affiliation: Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Yasukawa
authors.affiliation: Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan.
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Kudo
authors.affiliation: Clinical Research Center, Kinki University Hospital, Osaka-sayama, Japan.
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Chiba
authors.affiliation: The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ogura
authors.affiliation: The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Higuchi
authors.affiliation: Department of Cancer Survey and Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Nobuyasu
authors.initials: N
authors.lastname: Fukutake
authors.affiliation: Department of Cancer Survey and Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Reiko
authors.initials: R
authors.lastname: Ashida
authors.affiliation: Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan.
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Yamasaki
authors.affiliation: Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan.
authors.forename: Hiroko
authors.initials: H
authors.lastname: Nebiki
authors.affiliation: Department of Gastroenterology, Bell Land General Hospital, Sakai, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Hirose
authors.affiliation: Department of Gastroenterology, Bell Land General Hospital, Sakai, Japan.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Hoki
authors.affiliation: Digestive Disease Center, Kitano Hospital, Osaka, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Asada
authors.affiliation: Digestive Disease Center, Kitano Hospital, Osaka, Japan.
authors.forename: Shujiro
authors.initials: S
authors.lastname: Yazumi
authors.affiliation: The Third Department of Internal Medicine, Kansai Medical University, Hirakata, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Takaoka
authors.affiliation: The Third Department of Internal Medicine, Kansai Medical University, Hirakata, Japan.
authors.forename: Kazuichi
authors.initials: K
authors.lastname: Okazaki
authors.affiliation: Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.
authors.forename: Fumihiro
authors.initials: F
authors.lastname: Matsuda
authors.affiliation: Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Okabe
authors.affiliation: Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Yanagisawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009339:Needles; D015588:Observer Variation; D010190:Pancreatic Neoplasms / Q000175:diagnosis* / Q000473:pathology*; D011446:Prospective Studies; D012680:Sensitivity and Specificity