JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

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
Gastrointestinal Endoscopy 2014, 80 (6): 1030-7.e1
24890422

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.).

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