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

Ken Kamata; Masayuki Kitano; Satoru Yasukawa; Masatoshi Kudo; Yasutaka Chiba; Takeshi Ogura; Kazuhide Higuchi; Nobuyasu Fukutake; Reiko Ashida; Tomoaki Yamasaki; Hiroko Nebiki; Satoru Hirose; Noriyuki Hoki; Masanori Asada; Shujiro Yazumi; Makoto Takaoka; Kazuichi Okazaki; Fumihiro Matsuda; Yoshihiro Okabe; Akio Yanagisawa

doi:10.1055/s-0042-106294

Endoscopy, Table of Contents

Endoscopy 2016; 48(07): 632-638
DOI: 10.1055/s-0042-106294

Original article

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

Ken Kamata

¹Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan

,

Masayuki Kitano

¹Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan

,

Satoru Yasukawa

²Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan

,

Masatoshi Kudo

¹Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine, Osaka-sayama, Japan

,

Yasutaka Chiba

³Clinical Research Center, Kinki University Hospital, Osaka-sayama, Japan

,

Takeshi Ogura

⁴The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan

,

Kazuhide Higuchi

⁴The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan

,

Nobuyasu Fukutake

⁵Department of Cancer Survey and Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

,

Reiko Ashida

⁵Department of Cancer Survey and Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

,

Tomoaki Yamasaki

⁶Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan

,

Hiroko Nebiki

⁶Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan

,

Satoru Hirose

⁷Department of Gastroenterology, Bell Land General Hospital, Sakai, Japan

,

Noriyuki Hoki

⁷Department of Gastroenterology, Bell Land General Hospital, Sakai, Japan

,

Masanori Asada

⁸Digestive Disease Center, Kitano Hospital, Osaka, Japan

,

Shujiro Yazumi

⁸Digestive Disease Center, Kitano Hospital, Osaka, Japan

,

Makoto Takaoka

⁹The Third Department of Internal Medicine, Kansai Medical University, Hirakata, Japan

,

Kazuichi Okazaki

⁹The Third Department of Internal Medicine, Kansai Medical University, Hirakata, Japan

,

Fumihiro Matsuda

¹⁰Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan

,

Yoshihiro Okabe

¹⁰Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan

,

Akio Yanagisawa

²Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan

› Author Affiliations

Abstract

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.

Full Text

References

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