Nayar Manu K, Paranandi Bharat, Dawwas Muhammad F, Leeds John S, Darne Antony, Haugk Beate, Majumdar Debasis, Ahmed Muna M, Oppong Kofi W
HPB Unit, Freeman Hospital, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, United Kingdom.
HPB Unit, Freeman Hospital, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, United Kingdom; Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, United Kingdom.
Gastrointest Endosc. 2017 May;85(5):1017-1024. doi: 10.1016/j.gie.2016.08.048. Epub 2016 Sep 12.
A new core biopsy needle with a novel tip, opposing bevel, and sheath design has recently been introduced for EUS-guided fine-needle biopsy (FNB). The diagnostic utility of this needle for differentiating solid pancreatic masses is currently unknown. The aim of this study was to compare the diagnostic performance and yield for tissue acquisition from solid pancreatic lesions of the opposing bevel needle with those of a reverse bevel EUS-FNB needle.
Consecutive patients with solid pancreatic masses undergoing EUS-FNB using the opposing bevel (n = 101) and the reverse bevel (n = 100) core biopsy needles were included in the study. Final diagnosis was based on positive histology or at least 12 months of follow-up in cases with a negative biopsy. The primary outcome was the diagnostic performance of the 2 needles for malignant pancreatic masses. A secondary outcome was the diagnostic yield.
Compared with the reverse bevel needle, using strict criteria the opposing bevel needle provided significantly higher sensitivity (71.1% vs 90.1%; P = .0006) and overall accuracy (74% vs 92%; I = 0.0006) for discriminating malignant from benign solid pancreatic masses. The proportion of samples classified as adequate for histologic analysis was 87% for the reverse bevel needle versus 99% for the opposing bevel needle (p = 0.002) Multivariate analysis controlling the needle gauge and site did not show any significant difference in accuracy and sensitivity between the 2 groups. There were no adverse events in either group.
In this first, large, single-center preliminary cohort study, an EUS core biopsy needle with a novel tip, opposing bevel, and sheath design afforded substantially superior tissue yield and diagnostic performance compared with a reverse-bevel needle. If replicated by randomized controlled trials, our findings suggest that similarly designed needles could become the standard of care for EUS-guided tissue acquisition from solid pancreatic masses.
最近推出了一种新型的粗针活检针，其针尖、对侧斜面和针鞘设计新颖，用于超声内镜引导下细针穿刺活检（FNB）。目前尚不清楚这种针在鉴别实性胰腺肿块方面的诊断效用。本研究的目的是比较对侧斜面针与反向斜面超声内镜FNB针从实性胰腺病变获取组织的诊断性能和取材成功率。
本研究纳入了连续使用对侧斜面活检针（n = 101）和反向斜面活检针（n = 100）进行超声内镜FNB的实性胰腺肿块患者。最终诊断基于活检阳性的组织学结果，或活检阴性病例至少12个月的随访结果。主要结局是两种针对于恶性胰腺肿块的诊断性能。次要结局是诊断取材成功率。
与反向斜面针相比，采用严格标准时，对侧斜面针在鉴别良性与恶性实性胰腺肿块方面具有显著更高的敏感性（71.1% 对 90.1%；P = 0.0006）和总体准确性（74% 对 92%；P = 0.0006）。反向斜面针分类为适合组织学分析的样本比例为87%，而对侧斜面针为99%（P = 0.002）。控制针规格和取材部位的多因素分析显示，两组之间在准确性和敏感性方面没有显著差异。两组均未发生不良事件。
在这项首个大型单中心初步队列研究中，与反向斜面针相比，一种具有新颖针尖、对侧斜面和针鞘设计的超声内镜粗针活检针在组织取材成功率和诊断性能方面具有显著优势。如果随机对照试验能重复本研究结果，我们的发现表明，类似设计的针可能成为超声内镜引导下从实性胰腺肿块获取组织的标准治疗方法。
