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一项关于带侧孔与不带侧孔的内镜超声引导下细针穿刺（EUSFNA）针在胰腺肿块诊断率差异的前瞻性随机研究。

A prospective randomized study of the difference in diagnostic yield between endoscopic ultrasound-guided fine-needle aspiration (EUSFNA) needles with and without a side port in pancreatic masses.

作者信息

Ang Tiing Leong, Kwek Andrew Boon Eu, Seo Dong Wan, Paik Woo Hyun, Cheng Tsu-Yao, Wang Hsiu-Po, Lau James

机构信息

Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore.

Division of Gastroenterology, Asan Medical Centre, Seoul, Korea.

出版信息

Endosc Int Open. 2015 Aug;3(4):E329-33. doi: 10.1055/s-0034-1391964. Epub 2015 May 26.

DOI:10.1055/s-0034-1391964
PMID:26356802
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4554507/
Abstract

BACKGROUND AND STUDY AIMS

Two 22G needles with similar designs, apart from the absence (A) or presence of a side port (B), are available for endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA). The side port was designed to increase diagnostic yield but this advantage was unproven. This study evaluated the difference in diagnostic yield between both needles in pancreatic masses.

PATIENTS AND METHODS

This was a prospective multicenter randomized cross-over study. Patients with pancreatic masses were randomized to one needle for the first two passes, followed by the other for the next two passes. A pathologist blinded to the needle assessed each puncture for cellularity and morphology. The diagnostic yield between both needles was compared.

RESULTS

In total, 30 patients were recruited (mean lesion size: 3.5 cm, range: 1.2 - 6.3). Comparison of cellularity adequacy: first pass: A vs. B: 26/30 vs. 24/30 (P = 0.488): 2nd pass: A vs. B: 25/30 vs. 26/30 (P = 0.718). Comparison of diagnostic accuracy: first pass: A vs. B: 22/30 vs. 23/30 (P = 0.766); after two passes: A vs. B: 26/30 vs. 26/30 (P = 1.0). When all four passes were assessed, adequate cellularity was obtained in 29/30 and the correct diagnosis was obtained in 28/30 patients. There were no procedural complications.

CONCLUSIONS

There was no significant difference in diagnostic yield between EUSFNA needles with or without a side port for pancreatic masses.

STUDY REGISTRATION

NCT02092519.

摘要

背景与研究目的

除了无侧孔（A）或有侧孔（B）外，两种设计相似的22G针可用于内镜超声（EUS）引导下细针穿刺抽吸（FNA）。侧孔的设计旨在提高诊断率，但这一优势尚未得到证实。本研究评估了两种针在胰腺肿块诊断率上的差异。

患者与方法

这是一项前瞻性多中心随机交叉研究。胰腺肿块患者在前两次穿刺中随机使用一种针，随后两次穿刺使用另一种针。一位对针不知情的病理学家评估每次穿刺的细胞量和形态。比较两种针的诊断率。

结果

共招募了30例患者（平均病变大小：3.5厘米，范围：1.2 - 6.3厘米）。细胞量充足性比较：第一次穿刺：A组与B组：26/30对24/30（P = 0.488）；第二次穿刺：A组与B组：25/30对26/30（P = 0.718）。诊断准确性比较：第一次穿刺：A组与B组：22/30对23/30（P = 0.766）；两次穿刺后：A组与B组：26/30对26/30（P = 1.0）。当评估全部四次穿刺时，29/30患者获得了充足的细胞量，28/30患者获得了正确诊断。无操作并发症。

结论

对于胰腺肿块，有侧孔和无侧孔的EUS-FNA针在诊断率上无显著差异。

研究注册

NCT02092519。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a817/4554507/178ffade630e/10-1055-s-0034-1391964-i192ei3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a817/4554507/e1b19e6899cf/10-1055-s-0034-1391964-i192ei1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a817/4554507/abe22e602273/10-1055-s-0034-1391964-i192ei2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a817/4554507/178ffade630e/10-1055-s-0034-1391964-i192ei3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a817/4554507/e1b19e6899cf/10-1055-s-0034-1391964-i192ei1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a817/4554507/abe22e602273/10-1055-s-0034-1391964-i192ei2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a817/4554507/178ffade630e/10-1055-s-0034-1391964-i192ei3.jpg

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