Introduction: A new core biopsy needle with a novel tapered stylet tip has been introduced for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB). The tapered point stylet is purported to improve ease of puncture, leading to improved tissue acquisition and accuracy. However, there are no data available in the published literature. The aim of this study was to compare the diagnostic performance of the tapered stylet needle with conventional end-cutting FNB needles for tissue acquisition from solid lesions.Methods: Patients who underwent EUS-FNB of a solid lesion using the tapered stylet FNB needle across four tertiary hepatopancreaticobiliary centres in the UK were included in the study. Demographic, clinical, and performance outcomes were included in the analysis. Diagnostic performance was compared with a similar cohort of patients who underwent EUS-FNB using standard end-cutting FNB needles with a blunt-tipped stylet. The primary outcome was accuracy for the diagnosis of malignancy.Results: A total of 270 patients were included for analysis; 129 patients (48%) had sampling with the novel tapered stylet tip needle, among which 50% were female, the median age was 69, 74% had pancreatic lesions, and 80% had a final diagnosis of malignancy; 141 control cases (52%) were included for comparison, among which 48% were female, the median age was 68, 67% had pancreatic lesions, and 72% had a final diagnosis of malignancy. The tapered stylet needle demonstrated a sensitivity of 90% and an NPV of 72% for the diagnosis of malignancy compared with 88% and 77% for controls (p= 0.147). The overall diagnostic accuracy of the tapered stylet needle was 92.2% compared with 91.5% for controls (p= 0.634).Conclusions: The novel tapered tip stylet FNB needle demonstrated comparable sensitivity, NPV, and diagnostic accuracy to conventional FNB needles. This is the first and largest study reporting results for this new needle. However, further large comparative studies are warranted to validate our results and to determine if the tapered stylet offers an advantage over the conventional design.
引言：一种配备新型锥形针芯尖端的内镜超声引导下细针穿刺活检针已应用于临床。该锥形针芯设计旨在提高穿刺便捷性，从而提升组织获取质量与诊断准确性，但目前尚未有公开文献数据支持。本研究旨在比较锥形针芯活检针与传统端切式活检针对实体病灶组织获取的诊断效能。 方法：本研究纳入英国四家三级肝胆胰中心接受锥形针芯活检针进行实体病灶内镜超声引导下细针穿刺活检的患者。分析涵盖人口统计学特征、临床资料及操作结果，并将其与使用标准钝头针芯端切式活检针的同类患者队列进行诊断效能比较。主要观察指标为恶性肿瘤诊断准确率。 结果：共270例患者纳入分析。其中129例（48%）采用新型锥形针芯活检针取样，该组女性占比50%，中位年龄69岁，胰腺病灶占74%，最终确诊恶性病变者占80%；141例对照病例（52%）采用传统活检针，女性占比48%，中位年龄68岁，胰腺病灶占67%，最终确诊恶性病变者占72%。锥形针芯组诊断恶性肿瘤的敏感度为90%，阴性预测值为72%；对照组分别为88%和77%（p=0.147）。锥形针芯组总体诊断准确率为92.2%，对照组为91.5%（p=0.634）。 结论：新型锥形针芯活检针在诊断敏感度、阴性预测值及总体准确度方面与传统活检针表现相当。此为首次针对该新型穿刺针的大规模研究报告，但尚需进一步大型对照研究验证结果，并明确锥形针芯设计是否较传统设计更具优势。
Evaluation of a Novel Tapered Tip EUS-FNB Needle: A UK Multicentre Study
肿瘤(癌症)患者之家