Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Department of Endoscopy, Catholic University Rome, Rome, Italy.
Gastrointest Endosc. 2019 Feb;89(2):329-339. doi: 10.1016/j.gie.2018.10.026. Epub 2018 Oct 24.
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.
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.
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).
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.).
已有多项研究比较了超声内镜引导下细针穿刺抽吸术（EUS-FNA）与细针活检（FNB），但均未能证实其中任何一种方法具有优势。我们开展了一项多中心随机对照试验，旨在比较常用的 25G 细针抽吸针与新设计的 20G FNB 针的性能。
本国际多中心研究连续纳入了实体病灶患者，并对其进行 25G 细针抽吸（EchoTip Ultra）或 20G FNB 针（ProCore）的随机分组。主要终点为恶性肿瘤和 Bethesda 分类（非诊断性、良性、非典型、恶性）的诊断准确性。还评估了技术成功率、安全性和样本质量。进行了多变量和补充分析以调整混杂因素。
共纳入 608 例患者，分别接受 FNA（n=306）或 FNB（n=302）治疗；其中 312 例胰腺病变（51%）、147 例淋巴结（24%）和 149 例其他病变（25%）。25G 细针抽吸的技术成功率为 100%，20G FNB 针的技术成功率为 99%（P=0.043），不良事件发生率无差异。在组织学获得量（77% vs 44%，P<0.001）、恶性肿瘤诊断准确性（87% vs 78%，P=0.002）和 Bethesda 分类（82% vs 72%，P=0.002）方面，20G FNB 针均优于 25G 细针抽吸。在校正适应证、病变大小、穿刺次数和是否有现场病理学家后，这种差异仍然存在（优势比，3.53；95%置信区间，1.55-8.56；P=0.004），且不同中心之间无差异（P=0.836）。
20G FNB 针在组织学获得量和诊断准确性方面优于 25G 细针抽吸针。这种获益与适应证无关，且在参与中心中一致，支持我们研究结果的普遍适用性。（临床试验注册号：NCT02167074。）
