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在疑似结节病患者中,ProCore针与标准EBUS-TBNA针的诊断效能及安全性比较

Diagnostic yield and safety of the ProCore versus the standard EBUS-TBNA needle in subjects with suspected sarcoidosis.

作者信息

Dhooria Sahajal, Sehgal Inderpaul Singh, Prasad Kuruswamy Thurai, Muthu Valliappan, Gupta Nalini, Bal Amanjit, Ram Babu, Aggarwal Ashutosh Nath, Agarwal Ritesh

机构信息

Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

Department of Histopathology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Expert Rev Med Devices. 2021 Feb;18(2):211-216. doi: 10.1080/17434440.2021.1876560. Epub 2021 Jan 22.

Abstract

: No randomized trial has compared the yield of the ProCore needle, a novel needle for endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA), with standard needles.: Consecutive subjects with intrathoracic lymphadenopathy due to suspected sarcoidosis were randomized 1:1 to undergo EBUS-TBNA with either the 22-gauge ProCore (EchoTip-ProCore, Cook-Medical) or the 22-gauge standard (Vizishot, Olympus) needle. The primary outcome was the diagnostic sensitivity; the secondary outcomes included the number of adequate aspirates obtained and procedure-related complications.: We randomized 100 (mean age, 43.4 years; 53% women) subjects. Of the 84 subjects finally diagnosed with sarcoidosis, the sensitivity of EBUS-TBNA was higher with the ProCore (36/42, 85.7%) versus the standard needle (31/42, 73.8%), although not statistically significant (p = 0.18). We obtained adequate aspirates in 95.2% and 90.5% subjects in the ProCore and the standard needle groups, respectively (p = 0.68). One complication (transient hypoxemia) occurred in each group. There were two incidences of the ProCore needle getting bent during the procedure.: We found no difference in the sensitivity, specimen adequacy, or safety of EBUS-TBNA when performed with the ProCore or the Olympus needle in subjects with sarcoidosis. Larger studies are required to confirm our findings.[clinicaltrials.gov: NCT03656003].

摘要

尚无随机试验比较过用于支气管内超声(EBUS)引导下经支气管针吸活检(TBNA)的新型针具ProCore针与标准针具的取材成功率。

因疑似结节病导致胸内淋巴结肿大的连续受试者按1:1随机分组,分别使用22G的ProCore针(EchoTip-ProCore,库克医疗公司)或22G的标准针(Vizishot,奥林巴斯公司)进行EBUS-TBNA。主要结局为诊断敏感性;次要结局包括获得的足够样本数量和与操作相关的并发症。

我们将100名受试者(平均年龄43.4岁;53%为女性)随机分组。在最终诊断为结节病的84名受试者中,ProCore针的EBUS-TBNA敏感性高于标准针(36/42,85.7%对比31/42,73.8%),尽管差异无统计学意义(p = 0.18)。ProCore针组和标准针组分别有95.2%和90.5%的受试者获得了足够样本(p = 0.68)。每组均发生1例并发症(短暂低氧血症)。操作过程中有2次ProCore针发生弯曲。

我们发现,在结节病受试者中使用ProCore针或奥林巴斯针进行EBUS-TBNA时,在敏感性、样本充足性或安全性方面没有差异。需要更大规模的研究来证实我们的发现。[临床试验.gov:NCT03656003]

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