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比较22G针与25G针在肺癌患者中进行支气管内超声引导下经支气管针吸活检诊断淋巴结转移的效率:一项前瞻性随机交叉研究。

Comparison of the efficiency of endobronchial ultrasound-guided transbronchial needle aspiration using a 22G needle versus 25G needle for the diagnosis of lymph node metastasis in patients with lung cancer: a prospective randomized, crossover study.

作者信息

Sakai Tetsuya, Udagawa Hibiki, Kirita Keisuke, Nomura Shogo, Itotani Ryo, Tamiya Yutaro, Sugimoto Akira, Ota Takahiro, Naito Tomoyuki, Izumi Hiroki, Nosaki Kaname, Ikeda Takaya, Zenke Yoshitaka, Matsumoto Shingo, Yoh Kiyotaka, Niho Seiji, Nakai Tokiko, Ishii Genichiro, Goto Koichi

机构信息

Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Biostatistics Division, Center for Research Administration and Support, National Cancer Center, Kashiwa, Japan.

出版信息

Transl Lung Cancer Res. 2021 Sep;10(9):3745-3758. doi: 10.21037/tlcr-21-480.

Abstract

BACKGROUND

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is generally performed for the diagnosis of hilar/mediastinal lymph node metastasis in patients with lung cancer. Recently, a 25-gauge (G) needle became available, but robust evidence of its usefulness in routine clinical practice is still lacking.

METHODS

A prospective randomized crossover trial was performed, in which patients with suspected hilar/mediastinal lymph node metastasis of lung cancer underwent EBUS-TBNA. The primary endpoint was the rate of yield histology specimens containing malignant cells.

RESULTS

From December 2018 to February 2020, 102 patients were randomly assigned to EBUS-TBNA using a 22G needle first, followed by a 25G needle (n=50) or EBUS-TBNA using a 25G needle first, followed by a 22G needle (n=52). There was no difference in the diagnostic yield of malignancy between the histology specimens obtained by using the 22G and 25G needles (75% 75%, respectively, P=0.37). The sizes of the tissue samples (16.4 4.9 mm, respectively) and number of malignant cells in the tissue samples (626 400, respectively) were both significantly higher when using the 22G needle than when using the 25G needle.

CONCLUSIONS

No significant difference in the diagnostic yield between the 22G and 25G needles was observed for the diagnosis of lymph node metastasis of lung cancer, suggesting that needles of either gauge could be used for the biopsy. However, we would recommend use of the 22G needle, because it provided larger specimens and specimens containing larger numbers of malignant cells.

TRIAL REGISTRATION

University hospital Medical Information Network Clinical Trial Registry (ID: UMIN000036680).

摘要

背景

支气管内超声引导下经支气管针吸活检术(EBUS-TBNA)通常用于诊断肺癌患者的肺门/纵隔淋巴结转移。最近,一种25号(G)针已投入使用,但在常规临床实践中其有效性的有力证据仍然缺乏。

方法

进行了一项前瞻性随机交叉试验,其中疑似肺癌肺门/纵隔淋巴结转移的患者接受了EBUS-TBNA。主要终点是含有恶性细胞的组织学标本的阳性率。

结果

从2018年12月至2020年2月,102例患者被随机分配,先使用22G针进行EBUS-TBNA,然后使用25G针(n=50),或先使用25G针进行EBUS-TBNA,然后使用22G针(n=52)。使用22G针和25G针获得的组织学标本之间的恶性肿瘤诊断阳性率没有差异(分别为75%和75%,P=0.37)。使用22G针时,组织样本的大小(分别为16.4±4.9mm)和组织样本中恶性细胞的数量(分别为626±400)均显著高于使用25G针时。

结论

在诊断肺癌淋巴结转移方面,22G针和25G针的诊断阳性率没有显著差异,这表明两种规格的针均可用于活检。然而,我们建议使用22G针,因为它能提供更大的标本以及含有更多恶性细胞的标本。

试验注册

大学医院医学信息网络临床试验注册中心(编号:UMIN000036680)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/da34/8512458/14616baef697/tlcr-10-09-3745-f1.jpg

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