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超声内镜引导下的端切式细针活检针用于腹部和纵隔淋巴结病变的组织取样的诊断准确性和安全性:一项前瞻性多中心系列研究。

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.

机构信息

Division of Gastroenterology and Digestive Endoscopy.

Department of Pathology, Humanitas Research Center- IRCCS, Milan, Italy.

出版信息

Gastrointest Endosc. 2023 Aug;98(2):191-198. doi: 10.1016/j.gie.2023.03.018. Epub 2023 Mar 27.

DOI:10.1016/j.gie.2023.03.018
PMID:36990125
Abstract

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.).

摘要

背景与目的

新型超声内镜引导下细针穿刺活检(EUS-FNB)在淋巴结疾病(LAs)中的作用仍在评估中。本研究旨在评估 EUS-FNB 对 LAs 的诊断准确性和不良事件发生率。

方法

本研究纳入 2015 年 6 月至 2022 年 6 月期间因纵隔和腹部 LAs 接受 EUS-FNB 的 4 家机构的所有患者。使用 22 号 Frasen 尖端或 25 号叉状尖端针。阳性结果的标准为手术或影像学检查,以及至少 1 年的随访临床进展。

结果

共纳入 100 例连续患者,包括新发 LA(40%)、LA 伴先前肿瘤病史(51%)或疑似淋巴增生性疾病(9%)。所有 LA 患者均能通过 2 至 3 次穿刺完成 EUS-FNB(平均 2.62±0.93 次)。EUS-FNB 的总体敏感性、阳性预测值、特异性、阴性预测值和准确性分别为 96.20%、100%、100%、87.50%和 97.00%。89%的病例可进行组织学分析,67%的标本可进行细胞学评估。未发现 22 号和 25 号针的准确性有统计学差异(P=0.63)。对淋巴增生性疾病的亚分析显示,敏感性和准确性分别为 89.29%和 90.0%。未记录到不良事件。

结论

新型 EUS-FNB 是一种有价值且安全的方法,可用于诊断 LAs。高质量的组织芯和足够的组织量可进行转移性 LAs 的完整免疫组织化学分析,并对淋巴瘤进行精确分型。(临床试验注册号:NCT02855151)。

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