Mangiavillano Benedetto, Crinò Stefano Francesco, Facciorusso Antonio, Di Matteo Francesco, Barbera Carmelo, Larghi Alberto, Rizzatti Gianenrico, Carrara Silvia, Spadaccini Marco, Auriemma Francesco, Fabbri Carlo, Binda Cecilia, Coluccio Chiara, Marocchi Gianmarco, Staiano Teresa, Conti Bellocchi Maria Cristina, Bernardoni Laura, Eusebi Leonardo Henri, Cirota Giovanna Grazia, De Nucci Germana, Stigliano Serena, Manes Gianpiero, Bonanno Giacomo, Ofosu Andrew, Lamonaca Laura, Paduano Danilo, Spatola Federica, Repici Alessandro
Gastrointestinal Endoscopy Unit, Humanitas Mater Domini - Castellanza, Varese, Italy.
Humanitas University, Department of Biomedical Sciences, Pieve Emanuele, Milan, Italy.
Endoscopy. 2023 Feb;55(2):129-137. doi: 10.1055/a-1915-5263. Epub 2022 Aug 31.
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 %]; = 0.49), sample adequacy (93.1 % [95 %CI 88.6 %-96.3 %] vs. 95.5 % [95 %CI 91.4 %-98 %]; = 0.31), and rate of adverse events (2.6 % vs. 1.1 %; = 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3; < 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.
在使用22G Franseen针进行超声内镜引导下细针穿刺活检（EUS-FNB）时，应用宏观现场评估（MOSE）技术的优势尚未得到研究。我们旨在比较采用MOSE的EUS-FNB与进行三次针穿刺的EUS-FNB。
这项随机试验涉及10个意大利转诊中心。因胰腺或非胰腺实性病变接受EUS-FNB的连续患者被纳入研究并随机分为两组。MOSE通过内镜医师对收集的材料进行肉眼观察来进行，当获取到长度超过10毫米的白色/淡黄色聚集物核心时，认为是足够的。主要结局是诊断准确性。次要结局是样本充足性、针穿刺次数和安全性。
370例患者中有234例胰腺病变（63.2%）和136例非胰腺病变（36.8%）被随机分组（190例采用MOSE的EUS-FNB和180例采用标准EUS-FNB）。在诊断准确性（90.0% [95%CI 84.8%-93.9%] 对87.8% [95%CI 82.1%-92.2%]；P = 0.49）、样本充足性（93.1% [95%CI 88.6%-96.3%] 对95.5% [95%CI 91.4%-98%]；P = 0.31）和不良事件发生率（2.6%对1.1%；P = 0.28）方面，采用MOSE的EUS-FNB与传统EUS-FNB之间未发现统计学上的显著差异。采用MOSE的EUS-FNB组的针穿刺中位数显著更低（1次对3次；P < 0.001）。
采用MOSE的EUS-FNB的准确性不劣于进行三次针穿刺的EUS-FNB。MOSE能够可靠地评估样本充足性，并减少使用22G Franseen针获得诊断所需的针穿刺次数。
