A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device,Gastrointestinal Endoscopy

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A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device
Gastrointestinal Endoscopy ( IF 6.7 ) Pub Date : 2018-10-24 , DOI: 10.1016/j.gie.2018.10.026
Priscilla A. van Riet , Alberto Larghi , Fabia Attili , Guido Rindi , Nam Quoc Nguyen , Andrew Ruszkiewicz , Masayuki Kitano , Takaaki Chikugo , Harry Aslanian , James Farrell , Marie Robert , Adebowale Adeniran , Schalk Van Der Merwe , Tania Roskams , Kenneth Chang , Fritz Lin , John G. Lee , Paolo Giorgio Arcidiacono , Mariachiara Petrone , Claudio Doglioni , Julio Iglesias-Garcia , Ihab Abdulkader , Marc Giovannini , Erwan Bories , Flora Poizat , Erwin Santo , Erez Scapa , Silvia Marmor , Juan Carlos Bucobo , Jonathan M. Buscaglia , Alan Heimann , Maoxin Wu , Francisco Baldaque-Silva , Carlos Fernández Moro , Nicole S. Erler , Katharina Biermann , Jan-Werner Poley , Djuna L. Cahen , Marco J. Bruno

Background and Aims

Several studies have compared EUS-guided FNA with fine-needle biopsy (FNB), but none have proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle.

Methods

Consecutive patients with a solid lesion were randomized in this international multicenter study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). The primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification (non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample quality were also assessed. Multivariable and supplementary analyses were performed to adjust for confounders.

Results

A total of 608 patients were allocated to FNA (n = 306) or FNB (n = 302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (P = .043), with no differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histologic yield (77% vs 44%, P < .001), accuracy for malignancy (87% vs 78%, P = .002) and Bethesda classification (82% vs 72%, P = .002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (odds ratio, 3.53; 95% confidence interval, 1.55-8.56; P = .004), and did not differ among centers (P = .836).

Conclusion

The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histologic yield and diagnostic accuracy. This benefit was irrespective of the indication and was consistent among participating centers, supporting the general applicability of our findings. (Clinical trial registration number: NCT02167074.)

中文翻译：

一项多中心随机试验，对25口径EUS细针穿刺活检装置与20口径EUS细针活检装置进行了比较

背景和目标

几项研究将EUS引导的FNA与细针穿刺活检（FNB）进行了比较，但没有一项被证明具有优势。我们进行了一项多中心随机对照试验，比较了常用的25号FNA针和新设计的20号FNB针的性能。

方法

在这项国际多中心研究中，将连续性实体病变患者随机分为25号FNA（EchoTip Ultra）或20号FNB针（ProCore）。主要终点是恶性和贝塞斯达分类（非诊断，良性，非典型，恶性）的诊断准确性。还评估了技术上的成功，安全性和样品质量。进行多变量和补充分析以调整混杂因素。

结果

共有608名患者被分配到FNA（n = 306）或FNB（n = 302）；312个胰腺病变（51％），147个淋巴结（24％）和149个其他病变（25％）。25号FNA的技术成功率为100％，20号FNB针的技术成功率为99％（P = .043），不良事件无差异。就组织学产量（77％vs 44％，P <.001），恶性肿瘤准确度（87％vs 78％，P = .002）和贝塞斯达分类（82％）而言，20号FNB针优于25号FNA vs 72％，P = 0.002）。在校正适应症，病变大小，通过次数和现场病理医生的存在时，这种方法非常可靠（赔率，3.53； 95％置信区间，1.55-8.56；P = .004），并且各中心之间没有差异（P = .836）。