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比较22号与25号超声内镜细针穿刺活检针在实性肿块中性能的多中心随机对照试验。

Multicenter randomized controlled trial comparing the performance of 22 gauge versus 25 gauge EUS-FNA needles in solid masses.

作者信息

Vilmann Peter, Săftoiu Adrian, Hollerbach Stephan, Skov Birgit Guldhammer, Linnemann Dorte, Popescu Carmen Florina, Wellmann Axel, Gorunescu Florin, Clementsen Paul, Freund Ulrich, Flemming Peer, Hassan Hazem, Gheonea Dan Ionuţ, Streba Liliana, Ioncică Ana Maria, Streba Costin Teodor

机构信息

Department of Surgical Gastroenterology, Copenhagen University Hospital Herlev, Copenhagen, Denmark.

出版信息

Scand J Gastroenterol. 2013 Jul;48(7):877-83. doi: 10.3109/00365521.2013.799222.

DOI:10.3109/00365521.2013.799222
PMID:23795663
Abstract

BACKGROUND AND AIMS

Few randomized studies have assessed the clinical performance of 25-gauge (25G) needles compared with 22-gauge (22G) needles during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) biopsy of intra-abdominal lesions. We aimed to compare the diagnostic yield, as well as performance characteristics of 22G versus 25G EUS biopsy needles by determining their diagnostic capabilities, the number of needle passes as well as cellularity of aspirated tissue specimen.

METHODS

The study is a prospective, randomized, multicenter study. Patients were referred between January 2009 and January 2010 for diagnostic EUS including EUS-guided FNA of different lesions adjacent to the upper GI tract. All patients were randomized to EUS-FNA performed with either a 22G or 25G aspiration needle.

RESULTS

EUS-FNA was performed in 135 patients (62 patients with a 22G needle). Sensitivity and specificity of the 22G needle was 94.1% and 95.8%, respectively, and for the 25G needle 94.1% and 100%, respectively. Investigators reported better visualization and performance for the 22G needle compared to the 25G (p < 0.0001). The number of tissue slides obtained was higher for the 22G needle during the second and third needle passes (p < 0.05). We did not observe significant differences between the number and preservation status of obtained cells (p > 0.05).

CONCLUSIONS

A significant difference was found between the two types of needles in terms of reduced visualization of the 25G needle and suboptimal performance rating. However, this did not impact on overall results since both needles were equally successful in terms of a high diagnostic yield and overall accuracy.

摘要

背景与目的

在内镜超声引导下对腹腔内病变进行细针穿刺活检(EUS-FNA)时,与22号(22G)针相比,评估25号(25G)针临床性能的随机研究较少。我们旨在通过确定22G与25G EUS活检针的诊断能力、穿刺次数以及抽吸组织标本的细胞数量,比较它们的诊断率和性能特征。

方法

本研究为一项前瞻性、随机、多中心研究。2009年1月至2010年1月期间,将因诊断性EUS(包括对上消化道相邻不同病变进行EUS引导下FNA)而转诊的患者纳入研究。所有患者随机接受使用22G或25G抽吸针进行EUS-FNA。

结果

135例患者接受了EUS-FNA(62例使用22G针)。22G针的敏感性和特异性分别为94.1%和95.8%,25G针的敏感性和特异性分别为94.1%和100%。研究人员报告称,与25G针相比,22G针的可视化和性能更好(p < 0.0001)。在第二次和第三次穿刺时,22G针获得的组织切片数量更多(p < 0.05)。我们未观察到所获细胞数量及保存状态之间存在显著差异(p > 0.05)。

结论

发现两种针之间存在显著差异,25G针的可视化程度降低且性能评级欠佳。然而,这并未影响总体结果,因为两种针在高诊断率和总体准确性方面同样成功。

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