Taiki Kudo1, Hiroshi Kawakami1, Tsuyoshi Hayashi2, Ichiro Yasuda3, Tsuyoshi Mukai4, Hiroyuki Inoue5, Akio Katanuma6, Kazumichi Kawakubo7, Hirotoshi Ishiwatari2, Shinpei Doi3, Reiko Yamada5, Hiroyuki Maguchi6, Hiroyuki Isayama8, Tomoko Mitsuhashi9, Naoya Sakamoto1. 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 and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan; Department of Gastroenterology, The University of Tokyo, Tokyo, Japan. 8. Department of Gastroenterology, The University of Tokyo, Tokyo, Japan. 9. Department of Surgical Pathology, Hokkaido University Hospital, Sapporo, 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.).
RCT Entities:
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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