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Effect of antispasmodic drugs on endoscopic ultrasound/endoscopic ultrasound-guided fine-needle aspiration : A multicenter randomized controlled trial

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Title: Effect of antispasmodic drugs on endoscopic ultrasound/endoscopic ultrasound-guided fine-needle aspiration : A multicenter randomized controlled trial
Authors: Kuwatani, Masaki Browse this author →KAKEN DB
Kawakami, Hiroshi Browse this author →KAKEN DB
Hayashi, Tsuyoshi Browse this author →KAKEN DB
Eto, Kazunori Browse this author
Yamato, Hiroaki Browse this author
Onodera, Manabu Browse this author
Naruse, Hirohito Browse this author
Oba, Koji Browse this author →KAKEN DB
Keywords: Antispasmodic drug
endoscopic ultrasonography
endoscopic ultrasound-guided fine-needle aspiration
examination time
Issue Date: 2014
Publisher: Medknow
Journal Title: Endoscopic Ultrasound
Volume: 3
Issue: 3
Start Page: 167
End Page: 173
Publisher DOI: 10.4103/2303-9027.138788
Abstract: Background and Objective: Antispasmodic drugs (ADs) have been used to reduce examination time or improve the quality of gastrointestinal endoscopy, although the practice is controversial. No evidence about the efficacy of AD for endoscopic ultrasonography/EUS-guided fine-needle aspiration (EUS/EUS-FNA) is available. This study was aimed to evaluate the efficacy of AD in EUS/EUS-FNA. Patients and Methods: A total of 400 patients with pancreaticobiliary, peripancreatic, or peribiliary disease or disorder undergoing EUS/EUS-FNA were prospectively and evenly randomized to undergo EUS/EUS-FNA with AD (w-AD) or without AD (w/o-AD). The primary endpoint was total EUS/EUS-FNA examination time. The secondary endpoints were visual analogue scale (VAS) scores of endoscopists (patient body motion, gastrointestinal peristalsis, and accomplishment of the purpose) and patients (pain, discomfort, and willingness to undergo re-examination), vital sign changes, adverse events, and sedative dose. Results: Two hundred patients in the w-AD group and 197 patients in the w/o-AD group were ultimately analyzed. The total examination time was similar between the groups (2299 ± 937 vs. 2259 ± 1019 s). The difference in total examination time from w/o-AD group to w-AD group was −40 s (95% confidence interval, −234-153 s), which was within the noninferiority margin. No statistical differences were observed in endoscopist and patient VAS scores, changes in vital signs, adverse events, or total sedative dose other than fentanyl between the groups. Conclusion: EUS/EUS-FNA can be effectively and safely performed w/o-AD. Further, randomized controlled trials on EUS/EUS-FNA in various disease entities may be required to confirm the results of this study (UMIN000008047).
Type: article
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 桒谷 将城

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