Utility of Acquire 22G-fine needle biopsy (FNB) needle vs the standard 22G needle during Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomized Controlled Trial (RCT).

Expert review of medical devices Pub Date : 2024-10-07 DOI:10.1080/17434440.2024.2410913

Karan Madan, Saurabh Mittal, Sujay Halkur Shankar, Aruna Nambirajan, Deepali Jain, Pawan Tiwari, Vijay Hadda, Anant Mohan, Randeep Guleria

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Abstract

Background: Various types of needles are available to perform endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). A relatively new needle for EBUS-TBNA, the Acquire Fine Needle Biopsy (FNB) device, has recently become available.

Methods: Consecutive subjects with lymphadenopathy >1 cm undergoing EBUS-TBNA were randomized to the Acquire 22-G EBUS-FNB needle and the standard 22-G EBUS-TBNA needle groups.

Results: A total of 86 subjects were randomized (43 in each group). The diagnostic yield of EBUS-TBNA was similar between the two groups: (36/43) 83.7% in the 22-G EBUS-FNB group and (34/43) 79.1% in the standard 22-G EBUS group (p = 0.58). The sampling adequacy, stations sampled, number of stations sampled, number of needle passes, and mean duration of the procedure between the two groups were also similar. Visible tissue clot core was obtained in a significantly greater proportion of subjects in the 22-G EBUS-FNB group (93.0% vs 46.5%, p < 0.001). Visibly bloody samples were more frequent in the 22-G EBUS-FNB group (74.4% vs 51.2%, p = 0.03). There was no difference in the complication rates between the two groups (p = 0.15).

Conclusion: We did not observe a difference in the diagnostic yield of the Acquire 22-G EBUS-FNB needle compared with the standard 22-G EBUS needle.

Clinical trial registration: Clinical Trial Registry of India (CTRI) https://ctri.nic.in/ (CTRI/2021/08/035589).

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在支气管内超声引导下经支气管针吸术（EBUS-TBNA）中，Acquire 22G 细针活检（FNB）针与标准 22G 针的效用对比：随机对照试验 (RCT)。

背景：支气管内超声引导下经支气管针吸术（EBUS-TBNA）有多种针型可供选择。最近出现了一种相对较新的 EBUS-TBNA 针，即 Acquire 细针活检（FNB）装置：方法：将接受 EBUS-TBNA 检查的淋巴结肿大 >1 厘米的连续受检者随机分为 Acquire 22-G EBUS-FNB 针和标准 22-G EBUS-TBNA 针两组：结果：共有86名受试者接受了随机分组（每组43人）。两组的 EBUS-TBNA 诊断率相似：22-G EBUS-FNB 组为（36/43）83.7%，标准 22-G EBUS 组为（34/43）79.1%（p = 0.58）。两组的取样充分性、取样站、取样站数、穿刺针数和平均手术时间也相似。22-G EBUS-FNB 组获得可见组织凝块核心的比例明显更高（93.0% 对 46.5%，P = 0.03）。两组的并发症发生率没有差异（P = 0.15）：结论：我们没有观察到 Acquire 22-G EBUS-FNB 针与标准 22-G EBUS 针的诊断率有差异：临床试验注册：印度临床试验注册中心（CTRI）https://ctri.nic.in/ (CTRI/2021/08/035589)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Expert review of medical devices

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