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经支气管肺冷冻活检和外科肺活检:一项前瞻性多中心协议临床试验(CAN-ICE)。

Transbronchial Lung Cryobiopsy and Surgical Lung Biopsy: A Prospective Multi-Centre Agreement Clinical Trial (CAN-ICE).

机构信息

Department of Pulmonary Medicine and Thoracic Surgery.

Department of Surgery.

出版信息

Am J Respir Crit Care Med. 2023 Jun 15;207(12):1612-1619. doi: 10.1164/rccm.202209-1812OC.

DOI:10.1164/rccm.202209-1812OC
PMID:36796092
Abstract

Transbronchial cryobiopsy (TBCB) for the diagnosis of interstitial lung disease (ILD) has shown promising results, but prospective studies with matched surgical lung biopsy (SLB) have yielded conflicting results. We aimed to assess within- and between-center diagnostic agreement between TBCB and SLB at both the histopathologic and multidisciplinary discussion (MDD) levels in patients with diffuse ILD. In a multicenter prospective study, we performed matched TBCB and SLB in patients referred for SLB. After a blinded review by three pulmonary pathologists, all cases were reviewed by three independent ILD teams in an MDD. MDD was performed first with TBCB, then with SLB in a second session. Within-center and between-center diagnostic agreement was evaluated using percentages and correlation coefficients. Twenty patients were recruited and underwent contemporaneous TBCB and SLB. Within-center diagnostic agreement between TBCB-MDD and SLB-MDD was reached in 37 of the 60 (61.7%) paired observations, resulting in a Cohen's κ value of 0.46 (95% confidence interval [CI], 0.29-0.63). Diagnostic agreement increased among high-confidence or definitive diagnoses on TBCB-MDD (21 of 29 [72.4%]), but not significantly, and was more likely among cases with SLB-MDD diagnoses of idiopathic pulmonary fibrosis than fibrotic hypersensitivity pneumonitis (13 of 16 [81.2%] vs. 16 of 31 [51.6%];  = 0.047). Between-center agreement for cases was markedly higher for SLB-MDD (κ = 0.71 [95% CI, 0.52-0.89]) than TBCB-MDD (κ = 0.29 [95% CI, 0.09-0.49]). This study demonstrated moderate TBCB-MDD and SLB-MDD diagnostic agreement for ILD, while between-center agreement was fair for TBCB-MDD and substantial for SLB-MDD. Clinical trial registered with www.clinicaltrials.gov (NCT02235779).

摘要

经支气管冷冻活检(TBCB)在诊断间质性肺疾病(ILD)方面显示出良好的效果,但前瞻性研究显示,其与手术肺活检(SLB)的结果存在矛盾。我们旨在评估弥漫性ILD 患者的 TBCB 和 SLB 在组织病理学和多学科讨论(MDD)水平上的中心内和中心间诊断一致性。在一项多中心前瞻性研究中,我们对接受 SLB 治疗的患者进行了匹配的 TBCB 和 SLB。在三名肺病理学家进行盲法审查后,所有病例均由三个独立的ILD 团队在 MDD 中进行审查。首先在 TBCB 中进行 MDD,然后在第二次会议中进行 SLB。使用百分比和相关系数评估中心内和中心间的诊断一致性。共招募了 20 名患者,并同时进行了 TBCB 和 SLB。在 60 对(61.7%)配对观察中,TBCB-MDD 和 SLB-MDD 之间达到了中心内诊断一致性,柯恩氏κ值为 0.46(95%置信区间[CI],0.29-0.63)。在 TBCB-MDD 中具有高置信度或明确诊断的病例中,诊断一致性增加(29 例中有 21 例[72.4%]),但无统计学意义,且 SLB-MDD 诊断为特发性肺纤维化的病例比纤维化性过敏性肺炎更有可能(16 例中有 13 例[81.2%]比 31 例中有 16 例[51.6%]; = 0.047)。对于病例,SLB-MDD 的中心间一致性明显高于 TBCB-MDD(κ=0.71 [95% CI,0.52-0.89]),而 TBCB-MDD 的一致性为 0.29 [95% CI,0.09-0.49])。本研究表明,ILD 的 TBCB-MDD 和 SLB-MDD 诊断一致性中等,而 TBCB-MDD 的中心间一致性为差,SLB-MDD 的中心间一致性为好。本研究已在 www.clinicaltrials.gov 上注册(NCT02235779)。

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