Dataset related to article "Diagnostic accuracy and safety of EUS-guided end-cutting fine-needle biopsy needles for tissue sampling of abdominal and mediastinal lymphadenopathies: a prospective multicenter series"
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This record contains raw data related to article “Diagnostic accuracy and safety of EUS-guided end-cutting fine-needle biopsy needles for tissue sampling of abdominal and mediastinal lymphadenopathies: a prospective multicenter series" Background and aims: The role of the newer EUS fine-needle biopsy needles in lymphadenopathies (LAs) is still under evaluation. We aimed to evaluate the diagnostic accuracy and adverse event rate of EUS-guided fine-needle biopsy sampling (EUS-FNB) in diagnosing LAs. Methods: From June 2015 to June 2022, all patients referred to 4 institutions for EUS-FNB of mediastinal and abdominal LAs were enrolled. Twenty-two-gauge Franseen tip or 25-gauge fork-tip needles were used. The criterion standard for positive results was surgery or imaging and clinical evolution over a follow-up of at least 1 year. Results: One hundred consecutive patients were enrolled, consisting of those with a new diagnosis of LA (40%), presence of LA with a previous history of neoplasia (51%), or suspected lymphoproliferative disease (9%). EUS-FNB was technically feasible in all LA patients with 2 to 3 passes (mean, 2.62 ± .93). The overall sensitivity, positive predictive value, specificity, negative predictive value, and accuracy for EUS-FNB were 96.20%, 100%, 100%, 87.50%, and 97.00%, respectively. Histologic analysis was feasible in 89% of cases. Cytologic evaluation was performed in 67% of specimens. A statistical difference between the accuracy of the 22-gauge or 25-gauge needle (P = .63) was not found. A subanalysis on lymphoproliferative disease revealed a sensitivity and accuracy of 89.29% and 90.0%, respectively. No adverse events were recorded. Conclusions: EUS-FNB with new end-cutting needles is a valuable and safe method to diagnose LAs. The high quality of histologic cores and the good amount of tissue allowed a complete immunohistochemical analysis of metastatic LAs and precise subtyping of the lymphomas. (Clinical trial registration number: NCT02855151.).
本数据集收录了与题为《超声内镜（Endoscopic Ultrasound, EUS）引导下终切割式细针活检针用于腹部及纵隔淋巴结病变（lymphadenopathies, LAs）组织取样的诊断准确性与安全性：一项前瞻性多中心系列研究》的文章相关的原始数据。 背景与目的：新型EUS细针活检针在淋巴结病变中的应用价值仍待进一步评估。本研究旨在评估EUS引导下细针活检取样（EUS-guided fine-needle biopsy sampling, EUS-FNB）诊断淋巴结病变的准确性及不良事件发生率。 研究方法：2015年6月至2022年6月，纳入4家医疗机构中因纵隔及腹部淋巴结病变接受EUS-FNB检查的全部连续入组患者。活检针采用22号弗兰森尖端针或25号叉形尖端针。阳性结果的金标准为手术病理、影像学检查结果及至少1年随访期内的临床转归。 研究结果：共纳入100例连续入组患者，其中新诊断淋巴结病变者占40%，有肿瘤病史伴淋巴结病变者占51%，疑似淋巴增殖性疾病者占9%。所有患者均顺利完成EUS-FNB操作，活检次数为2~3次（平均2.62±0.93次）。EUS-FNB的总体灵敏度、阳性预测值、特异度、阴性预测值及准确率分别为96.20%、100%、100%、87.50%及97.00%。89%的病例可完成组织学分析，67%的标本完成了细胞学评估。22号与25号活检针的诊断准确率无统计学差异（P=0.63）。针对淋巴增殖性疾病的亚组分析显示，其灵敏度与准确率分别为89.29%与90.0%。本研究未记录到任何不良事件。 研究结论：采用新型终切割式活检针的EUS-FNB是诊断淋巴结病变的有效且安全的方法。高质量的组织芯与充足的组织样本可支持转移性淋巴结病变的完整免疫组化分析，以及淋巴瘤的精准分型。（临床试验注册号：NCT02855151.）
