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High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial - 01/06/16

Doi : 10.1016/j.gie.2014.04.012 
Taiki Kudo, MD 1, ∗, Hiroshi Kawakami, MD, PhD 1, ∗⁎, Tsuyoshi Hayashi, MD, PhD 2, Ichiro Yasuda, MD, PhD 3, Tsuyoshi Mukai, MD, PhD 4, Hiroyuki Inoue, MD, PhD 5, Akio Katanuma, MD, PhD 6, Kazumichi Kawakubo, MD, PhD 1, 7, Hirotoshi Ishiwatari, MD, PhD 2, Shinpei Doi, MD, PhD 3, Reiko Yamada, MD, PhD 5, Hiroyuki Maguchi, MD, PhD 6, Hiroyuki Isayama, MD, PhD 7, Tomoko Mitsuhashi, MD, PhD 8, Naoya Sakamoto, MD, PhD 1
for the

Japan EUS-FNA Negative Pressure Suction Study Group

H. Kawakami, MD, PhD, T. Kudo, MD, M. Kuwatani, MD, PhD, K. Eto, MD, PhD, Y. Abe, MD, S. Kawahata, MD, N. Sakamoto, MD, PhD, T. Mitsuhashi, MD, PhD, Y. Matsuno, MD, PhD, K. Marukawa, CT (IAC), J. Moriya, CT (IAC), K. Oba, PhD, T. Hayashi, MD, PhD, Y. Ishiwatari, MD, PhD, M. Ono, MD, T. Hasegawa, MD, PhD, K. Nakanishi, MD, PhD, J. Ogino, MD, PhD, H. Sanuma, PhD, CT (IAC), I. Yasuda, MD, PhD, S. Doi, MD, PhD, K. Toda, MD, PhD, T. Yamauchi, MD, PhD, J. Kawaguchi, MD, PhD, S. Uemura, MD, PhD, Y. Hirose, MD, PhD, T. Mukai, MD, PhD, M. Nakashima, MD, PhD, T. Yamada, MD, PhD, M. Etori, CT (IAC), T. Inoue, MD, PhD, R. Yamada, MD, PhD, Y. Takei, MD, PhD, T. Shiraishi, MD, PhD, M. Yoneda, CT (IAC), A. Katanuma, MD, H. Maguchi, MD, PhD, K. Yane, MD, T. Shinohara, MD, PhD, T. Sugimura, CT (IAC), Y. Nakajima, CT (IAC), K. Kawakubo, MD, PhD, H. Isayama, MD, PhD, Y. Nakai, MD, PhD, N. Yamamoto, MD, PhD, M. Tanaka, MD, PhD

1 Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan 
2 Department of Medical Oncology and Hematology, Sapporo Medical University, Sapporo, Japan 
3 The First Department of Internal Medicine, Gifu University Hospital, Gifu, Japan 
4 Department of Gastroenterology, Gifu Municipal Hospital, Gifu, Japan 
5 Department of Gastroenterology and Hepatology, Mie University, Mie, Japan 
6 Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan 
7 Department of Gastroenterology, The University of Tokyo, Tokyo, Japan 
8 Department of Surgical Pathology, Hokkaido University Hospital, Sapporo, Japan 

∗Reprint requests: Hiroshi Kawakami, MD, PhD, Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan.

Abstract

Background

EUS-guided FNA (EUS-FNA) has a high diagnostic accuracy for pancreatic diseases. However, although most reports have typically focused on cytology, histological tissue quality has rarely been investigated. The effectiveness of EUS-FNA combined with high negative pressure (HNP) suction was recently indicated for tissue acquisition, but has not thus far been tested in a prospective, randomized clinical trial.

Objective

To evaluate the adequacy of EUS-FNA with HNP for the histological diagnosis of pancreatic lesions by using 25-gauge needles.

Design

Prospective, single-blind, randomized, controlled crossover trial.

Setting

Seven tertiary referral centers.

Patients

Patients referred for EUS-FNA of pancreatic solid lesions. From July 2011 to April 2012, 90 patients underwent EUS-FNA of pancreatic solid masses by using normal negative pressure (NNP) and HNP with 2 respective passes. The order of the passes was randomized, and the sample adequacy, quality, and histology were evaluated by a single expert pathologist.

Intervention

EUS-FNA by using NNP and HNP.

Main Outcome Measurements

The adequacy of tissue acquisition and the accuracy of histological diagnoses made by using the EUS-FNA technique with HNP.

Results

We found that 72.2% (65/90) and 90% (81/90) of the specimens obtained using NNP and HNP, respectively, were adequate for histological diagnosis (P = .0003, McNemar test). For 73.3% (66/90) and 82.2% (74/90) of the specimens obtained by using NNP and HNP, respectively, an accurate diagnosis was achieved (P = .06, McNemar test). Pancreatitis developed in 1 patient after this procedure, which subsided with conservative therapy.

Limitations

This was a single-blinded, crossover study.

Conclusion

Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition. (Clinical trial registration number: UMIN000005939.)

Il testo completo di questo articolo è disponibile in PDF.

Abbreviations : CI, EUS-FNA, HNP, NNP


Mappa


 This study was supported by the Japanese Foundation for Research and Promotion of Endoscopy Grant (H.K.). All authors disclosed no financial relationships relevant to this article.
 If you would like to chat with an author of this article, you may contact Dr Kawakami at [email protected].


© 2014  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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