Endoscopy 2016; 48(07): 632-638
DOI: 10.1055/s-0042-106294
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Histologic diagnosis of pancreatic masses using 25-gauge endoscopic ultrasound needles with and without a core trap: a multicenter randomized trial

Ken Kamata
1   Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan
,
Masayuki Kitano
1   Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan
,
Satoru Yasukawa
2   Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan
,
Masatoshi Kudo
1   Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan
,
Yasutaka Chiba
3   Clinical Research Center, Kinki University Hospital, Osaka-sayama, Japan
,
Takeshi Ogura
4   The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan
,
Kazuhide Higuchi
4   The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan
,
Nobuyasu Fukutake
5   Department of Cancer Survey and Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
,
Reiko Ashida
5   Department of Cancer Survey and Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan
,
Tomoaki Yamasaki
6   Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan
,
Hiroko Nebiki
6   Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan
,
Satoru Hirose
7   Department of Gastroenterology, Bell Land General Hospital, Sakai, Japan
,
Noriyuki Hoki
7   Department of Gastroenterology, Bell Land General Hospital, Sakai, Japan
,
Masanori Asada
8   Digestive Disease Center, Kitano Hospital, Osaka, Japan
,
Shujiro Yazumi
8   Digestive Disease Center, Kitano Hospital, Osaka, Japan
,
Makoto Takaoka
9   The Third Department of Internal Medicine, Kansai Medical University, Hirakata, Japan
,
Kazuichi Okazaki
9   The Third Department of Internal Medicine, Kansai Medical University, Hirakata, Japan
,
Fumihiro Matsuda
10   Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan
,
Yoshihiro Okabe
10   Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan
,
Akio Yanagisawa
2   Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan
› Author Affiliations
Further Information

Publication History

submitted 08 May 2015

accepted after revision 23 February 2016

Publication Date:
29 April 2016 (online)

Background and study aims: 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.

Patients and 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. Clinical trial number: UMIN000010021.