National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, Chinese Academy of Medical Sciences, China-Japan Friendship Hospital, 2 Yinghuayuan East Street, Chaoyang District, Beijing, 100029, China.
Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, 100730, China.
Lung. 2024 Oct;202(5):615-623. doi: 10.1007/s00408-024-00713-2. Epub 2024 Jun 23.
Transbronchial lung cryobiopsy (TBLC) is increasingly used to diagnose interstitial lung disease (ILD). The 1.1-mm cryoprobe has recently been available in clinical practice. The diagnostic yield and safety of TBLC using a 1.1-mm cryoprobe need to be confirmed.
A prospective, randomized controlled trial was conducted in patients with suspected ILD and randomly assigned to 1.1-mm and 1.9-mm cryoprobe groups. The primary outcome was the diagnostic yield of multidisciplinary discussion. Secondary outcomes were sample quality and incidence of complications. The tension and stress effects during TBLC onto the target lobe caused by 1.1-mm and 1.9-mm cryoprobes were also evaluated using finite element analysis.
A total of 224 patients were enrolled. No significant differences were observed in the diagnostic yield (80.4% vs. 79.5%, p = 0.845) and sample quality scores (5.73 ± 0.64 vs. 5.66 ± 0.77; p = 0.324) between the 1.9-mm cryoprobe group and 1.1-mm cryoprobe group. The average surface areas of samples in 1.1-mm cryoprobe group were smaller, while no difference in sample weights was observed. A decreased incidence of moderate bleeding was found in the 1.1-mm cryoprobe group (17.0% vs. 6.2%, p = 0.027), while there was no difference in the incidence of the pneumothorax, there was a trend to higher rate of pneumothorax in 1.1-mm group. In finite element analysis, the 1.1-mm cryoprobe required the largest tension and produced the largest stress.
Compared with a 1.9-mm cryoprobe, there was no difference in specimen quality or diagnostic rate but smaller sample size with a 1.1-mm cryoprobe. There was a decreased risk of moderate bleeding, but a trend towards increased risk for pneumothorax with 1.1-mm cryoprobe.
Clinicaltrials.gov identifier NCT04047667; registered August 4, 2019.
经支气管肺冷冻活检（TBLC）越来越多地用于诊断间质性肺疾病（ILD）。最近，1.1mm 的冷冻探针已在临床实践中应用。需要确认使用 1.1mm 冷冻探针进行 TBLC 的诊断率和安全性。
对疑似 ILD 的患者进行前瞻性、随机对照试验，并随机分为 1.1mm 和 1.9mm 冷冻探针组。主要结局是多学科讨论的诊断率。次要结局是样本质量和并发症发生率。还使用有限元分析评估了 1.1mm 和 1.9mm 冷冻探针对目标肺叶造成的 TBLC 时的张力和应力影响。
共纳入 224 例患者。1.9mm 冷冻探针组和 1.1mm 冷冻探针组的诊断率（80.4%比 79.5%，p=0.845）和样本质量评分（5.73±0.64 比 5.66±0.77；p=0.324）无显著差异。1.1mm 冷冻探针组样本的平均表面积较小，而样本重量无差异。1.1mm 冷冻探针组中度出血发生率降低（17.0%比 6.2%，p=0.027），气胸发生率无差异，但气胸发生率有升高趋势。在有限元分析中，1.1mm 冷冻探针需要最大的张力并产生最大的应力。
与 1.9mm 冷冻探针相比，1.1mm 冷冻探针的标本质量或诊断率无差异，但标本量较小。1.1mm 冷冻探针中度出血风险降低，但气胸风险增加趋势。
Clinicaltrials.gov 标识符 NCT04047667；2019 年 8 月 4 日注册。
