Northern Beaches Hospital, Sydney, New South Wales, Australia.
Sydney Adventist Hospital, Sydney, New South Wales, Australia.
Intern Med J. 2023 Aug;53(8):1390-1399. doi: 10.1111/imj.15833. Epub 2022 Jul 21.
Computed tomography-guided transthoracic biopsy (CT-TTB) is the 'gold standard' biopsy for lung nodules. Radial-endobronchial ultrasound (R-EBUS) bronchoscopy is another recommended biopsy but carries a lower diagnostic yield. Addition of cryobiopsy with R-EBUS (Cryo-Radial) has shown promising results. There are no studies comparing CT-TTB with Cryo-Radial biopsy.
The co-primary aims were the diagnostic yeild and safety. The secondary aim: ability to test epidermal growth factor receptor (EGFR).
A randomised controlled, multicentre exploratory study was conducted at three tertiary hospitals. Patients with nodules >1 cm on CT of the chest were randomised to CT-TTB or Cryo-Radial. With Cryo-Radial, patients had 1-3 cryo-biopsies in addition to at least one R-EBUS biopsy through the 2.6 mm guide sheath.
Forty-eight patients were randomised: 22 to CT-TTB and 26 to Cryo-Radial. Sixteen in the CT-TTB and 20 in the Cryo-Radial received the allocated biopsy. The diagnostic yield was CT-TTB 93.8% (15/16) versus Cryo-Radial 85% (17/20) P = 0.61 and the odds ratio was 0.37. For 5/13 (38%), a diagnosis was solely made on cryobiopsy. Eleven (78%) of 14 in CT-TTB versus 7/10 (70%) Cryo-Radial were suitable for EGFR testing P = 0.66, with odds ratio 0.63. Pneumothorax occurrence was 44% (7/16) in CT-TTB versus 4.2% (1/24) in Cryo-Radial. Two (12.5%) of 16 CT-TTB required chest drain insertion.
Cryo-Radial is comparable in diagnostic yield and ability to perform EGFR testing with a significantly lower risk of pneumothorax, compared with CT-TTB. Cryo-Radial has the additional advantage of mediastinal staging during the same procedure with Linear-EBUS and is a promising first-line tool in the diagnostic method of lung cancer.
计算机断层扫描引导经胸活检（CT-TTB）是肺结节的“金标准”活检。径向支气管内超声（R-EBUS）支气管镜检查也是另一种推荐的活检方法，但诊断率较低。在 R-EBUS 中加入冷冻活检（Cryo-Radial）已显示出有希望的结果。目前尚无比较 CT-TTB 与 Cryo-Radial 活检的研究。
主要的共同目的是诊断效果和安全性。次要目的：检测表皮生长因子受体（EGFR）的能力。
在三家三级医院进行了一项随机对照、多中心探索性研究。胸部 CT 显示直径大于 1 厘米的结节的患者被随机分为 CT-TTB 或 Cryo-Radial 组。在 Cryo-Radial 组中，除了通过 2.6mm 引导鞘进行至少一次 R-EBUS 活检外，患者还进行了 1-3 次冷冻活检。
48 名患者被随机分配：22 名接受 CT-TTB，26 名接受 Cryo-Radial。CT-TTB 组 16 名和 Cryo-Radial 组 20 名接受了分配的活检。CT-TTB 的诊断率为 93.8%（15/16），Cryo-Radial 为 85%（17/20），P=0.61，优势比为 0.37。对于 13 例中的 5 例（38%），仅通过冷冻活检即可确诊。CT-TTB 组 14 例中有 11 例（78%），Cryo-Radial 组 10 例中有 7 例（70%）适合进行 EGFR 检测，P=0.66，优势比为 0.63。CT-TTB 组气胸发生率为 44%（7/16），Cryo-Radial 组为 4.2%（1/24）。CT-TTB 组有 2 名（12.5%）患者需要放置胸腔引流管。
与 CT-TTB 相比，Cryo-Radial 在诊断效果和进行 EGFR 检测方面相当，但气胸风险显著降低。Cryo-Radial 还有一个额外的优势，即在同一程序中使用线性超声支气管镜（Linear-EBUS）进行纵隔分期，是肺癌诊断方法的一种很有前途的一线工具。
