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Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial

医学 随机对照试验 内镜超声 细针活检 放射科 胰腺癌 活检 核医学 外科 内科学 细针穿刺 癌症
作者
Benedetto Mangiavillano,Stefano Francesco Crinò,Antonio Facciorusso,Francesco Di Matteo,Carmelo Barbera,Alberto Larghi,Gianenrico Rizzatti,Silvia Carrara,Marco Spadaccini,Francesco Auriemma,Carlo Fabbri,Cecilia Binda,Chiara Coluccio,Gianmarco Marocchi,Teresa Staiano,Maria Cristina Conti Bellocchi,Laura Bernardoni,Leonardo Henry Eusebi,Giovanna Grazia Cirota,Germana de Nucci,Serena Stigliano,Gianpiero Manes,Giacomo Bonanno,Andrew Ofosu,Laura Lamonaca,Danilo Paduano,Federica Spatola,Alessandro Repici
出处
期刊:Endoscopy [Thieme Medical Publishers (Germany)]
卷期号:55 (02): 129-137 被引量:29
标识
DOI:10.1055/a-1915-5263
摘要

Background The advantage of using the macroscopic on-site evaluation (MOSE) technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) performed with 22G Franseen needles has not been investigated. We aimed to compare EUS-FNB with MOSE vs. EUS-FNB performed with three needle passes. Methods This randomized trial involved 10 Italian referral centers. Consecutive patients referred for EUS-FNB of pancreatic or nonpancreatic solid lesions were included in the study and randomized to the two groups. MOSE was performed by gross visualization of the collected material by the endoscopists and considered adequate when a white/yellowish aggregate core longer than 10 mm was retrieved. The primary outcome was diagnostic accuracy. Secondary outcomes were specimen adequacy, number of needle passes, and safety. Results 370 patients with 234 pancreatic lesions (63.2 %) and 136 nonpancreatic lesions (36.8 %) were randomized (190 EUS-FNB with MOSE and 180 with standard EUS-FNB). No statistically significant differences were found between EUS-FNB with MOSE and conventional EUS-FNB in terms of diagnostic accuracy (90.0 % [95 %CI 84.8 %–93.9 %] vs. 87.8 % [95 %CI 82.1 %–92.2 %]; P = 0.49), sample adequacy (93.1 % [95 %CI 88.6 %–96.3 %] vs. 95.5 % [95 %CI 91.4 %–98 %]; P = 0.31), and rate of adverse events (2.6 % vs. 1.1 %; P = 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3; P < 0.001). Conclusions The accuracy of EUS-FNB with MOSE is noninferior to that of EUS-FNB with three needle passes. MOSE reliably assesses sample adequacy and reduces the number of needle passes required to obtain the diagnosis with a 22G Franseen needle.
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