一项使用 22G Franseen 针进行内镜超声引导下细针活检诊断胰腺实性病变的前瞻性多中心研究。

A prospective multicenter study of endoscopic ultrasound-guided fine needle biopsy using a 22-gauge Franseen needle for pancreatic solid lesions.

机构信息

Department of Gastroenterology, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.

Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.

出版信息

J Gastroenterol Hepatol. 2021 Oct;36(10):2754-2761. doi: 10.1111/jgh.15534. Epub 2021 May 14.

DOI:10.1111/jgh.15534

PMID:33939863

Abstract

BACKGROUND AND AIM

While encouraging data of endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) using a 22-gauge Franseen needle have been reported, large-scale data of per pass and quantitative analyses are still lacking.

METHODS

This was a multicenter prospective study of EUS-FNB using the 22-gauge Franseen needle for a pancreatic solid lesion. Cytological and histological analyses per pass were evaluated and semi-quantitative analyses were performed on core tissue and blood contamination. Primary end-point was diagnostic accuracy per session. Prognostic factors were analyzed for diagnostic accuracy, sensitivity, core tissue, and blood contamination.

RESULTS

A total of 629 passes were performed in 244 cases at 14 centers between 2018 and 2019. The median tumor size was 29 mm, and the puncture was transduodenal in 43%. The median pass number was 2. Diagnostic accuracy per session, at a first pass, and per pass were 93%, 90%, and 88%. In 198 cases with pancreatic cancer, diagnostic sensitivity per session, at a first pass, and per pass were 94%, 89%, and 89%. The rates of core tissue score of 4 and blood contamination score of 3 were 50% and 47%. The adverse event rate was 1.6%. In the multivariate analysis, tumor size ≤20 mm (odds ratio [OR] of 0.46, P = 0.03), transduodenal puncture (OR of 0.53, P = 0.04), and suction (OR of 0.16, P = 0.01) were associated with lower diagnostic accuracy.

CONCLUSIONS

The EUS-FNB using the 22-gauge Franseen needle for pancreatic solid lesions showed high per pass and overall diagnostic accuracy.

摘要

背景与目的

虽然已经报道了使用 22 号 Franseen 针进行内镜超声（EUS）引导下细针活检（EUS-FNB）的数据，但仍缺乏每针和定量分析的大规模数据。

方法

这是一项使用 22 号 Franseen 针对胰腺实性病变进行 EUS-FNB 的多中心前瞻性研究。每针进行细胞学和组织学分析，并对核心组织和血液污染进行半定量分析。主要终点为每针的诊断准确性。对诊断准确性、敏感性、核心组织和血液污染进行了预后因素分析。

结果

2018 年至 2019 年，在 14 个中心的 244 例患者中进行了 629 次穿刺。中位肿瘤大小为 29mm，43%为经十二指肠穿刺。中位穿刺次数为 2 次。初次穿刺、每针的诊断准确性分别为 93%、90%和 88%。在 198 例胰腺癌患者中，初次穿刺、每针的诊断敏感性分别为 94%、89%和 89%。核心组织评分 4 分和血液污染评分 3 分的比例分别为 50%和 47%。不良事件发生率为 1.6%。在多变量分析中，肿瘤大小≤20mm（比值比[OR]为 0.46，P=0.03）、经十二指肠穿刺（OR 为 0.53，P=0.04）和抽吸（OR 为 0.16，P=0.01）与较低的诊断准确性相关。