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).