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一种新型超声内镜核心活检针的多中心评估:200例患者的经验

A multicenter evaluation of a new EUS core biopsy needle: Experience in 200 patients.

作者信息

Adler Douglas G, Muthusamy V Raman, Ehrlich Dean S, Parasher Gulshan, Thosani Nirav C, Chen Ann, Buscaglia Jonathan M, Appannagari Anoop, Quintero Eduardo, Aslanian Harry, Taylor Linda Jo, Siddiqui Ali

机构信息

Department of Gastroenterology and Hepatology, University of Utah School of Medicine, Salt Lake City, Utah, USA.

Department of Gastroenterology and Hepatology, University of California, Los Angeles, California, USA.

出版信息

Endosc Ultrasound. 2019 Mar-Apr;8(2):99-104. doi: 10.4103/eus.eus_53_17.

Abstract

BACKGROUND AND OBJECTIVES

We present a multicenter study of a new endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) needle (Acquire, Boston Scientific, Natick, MA). The aim of the study was to analyze the needle's clinical performance when sampling solid lesions and to assess the safety of this device.

METHODS

We performed a multicenter retrospective study of patients undergoing EUS-FNB during July 1-November 15, 2016.

RESULTS

Two hundred patients (121 males and 79 females) underwent EUS-FNB of solid lesions with the Acquire needle. Lesions included solid pancreatic masses (n = 109), adenopathy (n = 45), submucosal lesions (n = 34), cholangiocarcinoma (n = 8), liver lesions (n = 6), and other (n = 8). Mean lesion size was 30.6 mm (range: 3-100 mm). The mean number of passes per target lesion was 3 (range: 1-7). Rapid onsite cytologic evaluation (ROSE) by a cytologist was performed in all cases. Tissue obtained by EUS-FNB was adequate for evaluation and diagnosis by ROSE in 197/200 cases (98.5%). Data regarding the presence or absence of a core of tissue obtained after EUS-FNB were available in 145/200 procedures. In 131/145 (90%) of cases, a core of tissue was obtained. Thirteen out of 200 patients (6.5%) underwent some form of repeat EUS-based tissue acquisition after EUS-FNB with the Acquire needle. There were no adverse events.

CONCLUSION

Overall, this study showed a high rate of tissue adequacy and production of a tissue core with this device with no adverse events seen in 200 patients. Comparative studies of different FNB needles are warranted in the future to help identify which needle type and size is ideal in different clinical settings.

摘要

背景与目的

我们开展了一项关于新型内镜超声引导下细针穿刺活检(EUS-FNB)针(Acquire,波士顿科学公司,马萨诸塞州纳蒂克)的多中心研究。本研究的目的是分析该针在对实性病变取样时的临床性能,并评估该设备的安全性。

方法

我们对2016年7月1日至11月15日期间接受EUS-FNB的患者进行了一项多中心回顾性研究。

结果

200例患者(121例男性和79例女性)使用Acquire针接受了实性病变的EUS-FNB。病变包括实性胰腺肿块(n = 109)、淋巴结病(n = 45)、黏膜下病变(n = 34)、胆管癌(n = 8)、肝脏病变(n = 6)以及其他病变(n = 8)。病变平均大小为30.6毫米(范围:3 - 100毫米)。每个目标病变的平均穿刺次数为3次(范围:1 - 7次)。所有病例均由细胞病理学家进行快速现场细胞学评估(ROSE)。EUS-FNB获取的组织在197/200例(98.5%)病例中足以通过ROSE进行评估和诊断。在145/200例操作中可获得关于EUS-FNB后是否获取到组织核心的数据。在131/145(90%)的病例中获取到了组织核心。200例患者中有13例(6.5%)在使用Acquire针进行EUS-FNB后接受了某种形式的基于EUS的重复组织获取。未发生不良事件。

结论

总体而言,本研究表明使用该设备获取组织的充足率高且能获取到组织核心,200例患者中未观察到不良事件。未来有必要对不同的FNB针进行比较研究,以帮助确定在不同临床环境中哪种针型和尺寸是理想的。

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