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

Taiki Kudo; Hiroshi Kawakami; Tsuyoshi Hayashi; Ichiro Yasuda; Tsuyoshi Mukai; Hiroyuki Inoue; Akio Katanuma; Kazumichi Kawakubo; Hirotoshi Ishiwatari; Shinpei Doi; Reiko Yamada; Hiroyuki Maguchi; Hiroyuki Isayama; Tomoko Mitsuhashi; Naoya Sakamoto

doi:10.1016/j.gie.2014.04.012

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

Taiki Kudo, Hiroshi Kawakami, Tsuyoshi Hayashi^*, Ichiro Yasuda, Tsuyoshi Mukai, Hiroyuki Inoue, Akio Katanuma, Kazumichi Kawakubo, Hirotoshi Ishiwatari, Shinpei Doi, Reiko Yamada, Hiroyuki Maguchi, Hiroyuki Isayama, Tomoko Mitsuhashi, Naoya Sakamoto

^*Corresponding author for this work

Internal Medicine （3）

Research output: Contribution to journal › Article › peer-review

78 Scopus citations

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.

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.).

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.

Original language	English
Pages (from-to)	1030-1037.e1
Journal	Gastrointestinal Endoscopy
Volume	80
Issue number	6
DOIs	https://doi.org/10.1016/j.gie.2014.04.012
State	Published - 2014/12/01

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging
Gastroenterology

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10.1016/j.gie.2014.04.012

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Kudo, T., Kawakami, H., Hayashi, T., Yasuda, I., Mukai, T., Inoue, H., Katanuma, A., Kawakubo, K., Ishiwatari, H., Doi, S., Yamada, R., Maguchi, H., Isayama, H., Mitsuhashi, T., & Sakamoto, N. (2014). 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. Gastrointestinal Endoscopy, 80(6), 1030-1037.e1. https://doi.org/10.1016/j.gie.2014.04.012

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title = "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",

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.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.).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.",

author = "Taiki Kudo and Hiroshi Kawakami and Tsuyoshi Hayashi and Ichiro Yasuda and Tsuyoshi Mukai and Hiroyuki Inoue and Akio Katanuma and Kazumichi Kawakubo and Hirotoshi Ishiwatari and Shinpei Doi and Reiko Yamada and Hiroyuki Maguchi and Hiroyuki Isayama and Tomoko Mitsuhashi and Naoya Sakamoto",

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doi = "10.1016/j.gie.2014.04.012",

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Kudo, T, Kawakami, H, Hayashi, T, Yasuda, I, Mukai, T, Inoue, H, Katanuma, A, Kawakubo, K, Ishiwatari, H, Doi, S, Yamada, R, Maguchi, H, Isayama, H, Mitsuhashi, T & Sakamoto, N 2014, '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', Gastrointestinal Endoscopy, vol. 80, no. 6, pp. 1030-1037.e1. https://doi.org/10.1016/j.gie.2014.04.012

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. / Kudo, Taiki; Kawakami, Hiroshi; Hayashi, Tsuyoshi et al.
In: Gastrointestinal Endoscopy, Vol. 80, No. 6, 01.12.2014, p. 1030-1037.e1.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles

T2 - A multicenter, prospective, randomized, controlled trial

AU - Kudo, Taiki

AU - Kawakami, Hiroshi

AU - Hayashi, Tsuyoshi

AU - Yasuda, Ichiro

AU - Mukai, Tsuyoshi

AU - Inoue, Hiroyuki

AU - Katanuma, Akio

AU - Kawakubo, Kazumichi

AU - Ishiwatari, Hirotoshi

AU - Doi, Shinpei

AU - Yamada, Reiko

AU - Maguchi, Hiroyuki

AU - Isayama, Hiroyuki

AU - Mitsuhashi, Tomoko

AU - Sakamoto, Naoya

PY - 2014/12/1

Y1 - 2014/12/1

N2 - 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.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.).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.

AB - 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.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.).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.

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U2 - 10.1016/j.gie.2014.04.012

DO - 10.1016/j.gie.2014.04.012

M3 - 学術論文

C2 - 24890422

AN - SCOPUS:84920149404

SN - 0016-5107

VL - 80

SP - 1030-1037.e1

JO - Gastrointestinal Endoscopy

JF - Gastrointestinal Endoscopy

IS - 6

ER -

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

Abstract

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