Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Department of Medicine, Gastroenterology and Digestive Endoscopy Unit, The Pancreas Institute, University Hospital of Verona, Verona, Italy.
Gastrointest Endosc. 2022 Jun;95(6):1067-1077.e15. doi: 10.1016/j.gie.2022.01.019. Epub 2022 Feb 4.
Evidence is limited on the comparative diagnostic performance of newer end-cutting fine-needle biopsy (FNB) needles for tissue sampling of pancreatic masses. We performed a systematic review with network meta-analysis to compare the diagnostic accuracy of available FNB needles for sampling of solid pancreatic lesions.
A systematic literature review (Medline and Cochrane Database) was conducted for studies evaluating the accuracy of newer FNB needles in adults undergoing EUS-guided sampling of solid pancreatic masses. The primary outcome was diagnostic accuracy. Secondary outcomes were sample adequacy, diagnostic sensitivity, specificity, and adverse event rate. We performed pairwise and network meta-analyses and appraised the quality of evidence using Grading of Recommendations Assessment, Development and Evaluation methodology.
Overall, 16 RCTs (1934 patients) were identified. On network meta-analysis, Franseen needles (Acquire; Boston Scientific, Marlborough, Mass, USA) significantly outperformed reverse-bevel needles (risk ratio [RR], 1.21 [95% confidence interval {CI}, 1.05-1.40] for accuracy and 1.31 [95% CI, 1.05-1.22] for adequacy) and FNA needles (RR, 1.21 [95% CI, 1.01-1.25] for accuracy and 1.07 [95% CI, 1.02-1.13] for adequacy). Likewise, the Fork-tip needle (SharkCore; Medtronic, Dublin, Ireland) was significantly superior to the reverse-bevel needle (RR, 1.17 [95% CI, 1.03-1.33] for accuracy and 1.09 [95% CI, 1.02-1.16] for adequacy) and to the FNA needle (RR, 1.09 [95% CI, 1.01-1.19] for accuracy and 1.03 [95% CI, 1.01-1.07] for adequacy). Other comparisons did not achieve statistical significance. As a consequence, Franseen (surface under the cumulative ranking score, .89 for accuracy and .94 for adequacy) and Fork-tip needles (surface under the cumulative ranking score, .76 for accuracy and .73 for adequacy) ranked as the 2 highest-performing FNB needles. When considering different needle sizes, 25-gauge Franseen and 25-gauge Fork-tip needles were not superior to 22-gauge reverse-bevel needles (RR, 1.18 [95% CI, .96-1.46] and 1.04 [95% CI, .62-1.52]). None of the tested needles was significantly superior to the other FNB devices or to FNA needles when rapid onsite cytologic evaluation was available.
Franseen and Fork-tip needles, particularly 22-gauge size, showed the highest performance for tissue sampling of pancreatic masses, with low confidence in estimates.
关于新型端切式细针活检（FNB）针在胰腺肿块组织取样方面的比较诊断性能，证据有限。我们进行了一项系统评价和网络荟萃分析，以比较现有的 FNB 针在成人 EUS 引导下对胰腺实性病变取样的诊断准确性。
对评估新型 FNB 针在接受 EUS 引导下胰腺实性肿块取样的成年人中的准确性的研究进行了系统的文献检索（Medline 和 Cochrane 数据库）。主要结果是诊断准确性。次要结果是样本充足性、诊断灵敏度、特异性和不良事件发生率。我们进行了两两比较和网络荟萃分析，并使用 Grading of Recommendations Assessment, Development and Evaluation 方法评估证据质量。
总体而言，确定了 16 项 RCT（1934 名患者）。在网络荟萃分析中，Fransen 针（Acquire；Boston Scientific，马萨诸塞州马尔伯勒，美国）在准确性（优势比[RR]，1.21[95%置信区间{CI}，1.05-1.40]）和充足性（RR，1.21[95%CI，1.01-1.25]）方面显著优于反向斜面针和 FNA 针，在充足性（RR，1.07[95%CI，1.02-1.13]）方面显著优于 FNA 针。同样，Fork-tip 针（SharkCore；Medtronic，都柏林，爱尔兰）在准确性（RR，1.17[95%CI，1.03-1.33]）和充足性（RR，1.09[95%CI，1.02-1.16]）方面显著优于反向斜面针和 FNA 针，在充足性（RR，1.03[95%CI，1.01-1.07]）方面显著优于 FNA 针。其他比较未达到统计学意义。因此，Fransen（累积排序得分曲面下面积，准确性为.89，充足性为.94）和 Fork-tip 针（累积排序得分曲面下面积，准确性为.76，充足性为.73）被评为表现最好的 2 种 FNB 针。当考虑不同的针大小时，25 号 Fransen 和 25 号 Fork-tip 针并不优于 22 号反向斜面针（RR，1.18[95%CI，.96-1.46]和 1.04[95%CI，.62-1.52]）。在可获得快速现场细胞学评估的情况下，没有一种测试的针在性能上明显优于其他 FNB 设备或 FNA 针。
Fransen 和 Fork-tip 针，特别是 22 号针，在胰腺肿块的组织取样方面表现出最高的性能，但其估计值置信度较低。
