Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease diagnosis (COLDICE): a prospective, comparative study
Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease diagnosis (COLDICE): a prospective, comparative study
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DOI：
10.1016/s2213-2600(19)30342-x
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发表时间：
2020-02-01
影响因子：
76.2
通讯作者：
Lau, Edmund M. T.
中科院分区：
文献类型：
--
作者：
Troy, Lauren K.;Grainge, Christopher;Lau, Edmund M. T.
经支气管肺冷冻活检（TBLC）是一种新的肺组织取样技术，用于间质性肺疾病的诊断。本研究的目的是建立TBLC的诊断准确性与手术肺活检（SLB）相比，在越来越多地使用TBLC在临床实践中作为一种微创活检technology.Methods COLDICE的背景下，是一个前瞻性的，多中心的，诊断准确性研究调查TBLC和SLB之间的诊断协议，在9个澳大利亚三级医院。年龄在18 - 80岁之间的间质性肺病患者，如果在详细的基线评价后需要组织病理学评价以辅助诊断，则有资格入选。在集中多学科讨论（MDD）筛选后，转诊进行肺活检的间质性肺病患者在一种麻醉剂下接受了序贯TBLC和SLB。每个组织样本被分配一个1到130之间的数字，以计算机生成的随机序列分配。然后由设盲的病理学家分析编码的活检样本。在随后的MDD中，以随机非连续顺序，使用TBLC或SLB沿着临床和影像学数据，对去识别病例进行了两次讨论。协同主要终点是TBLC和SLB中明确或很可能的普通型间质性肺炎、不确定的普通型间质性肺炎和替代诊断模式的组织病理学特征的一致性;以及MDD时使用TBLC和SLB的共识临床诊断的一致性。和谐与。计算每个主要终点的数值。本研究在澳大利亚新西兰临床试验注册中心注册，ACTRN 12615000718549。结果2016年3月15日至2019年4月15日，我们招募了65名患者（31例[48%]男性，34例[52%]女性;平均年龄66.1岁[SD 9.3];用力肺活量83.7% [SD 14.2];一氧化碳弥散量63.4% [SD 12.8]）。TBLC（7.1 mm，SD 1.9）和SLB（46.5 mm，14.9）样本分别取自两个单独的同侧肺叶。TBLC和SLB的组织学一致性为70.8%（加权）。0.70，95% CI 0.55-0.86）; MDD诊断一致率为76.9%（kappa 0.62，0.47-0.78）。对于MDD诊断置信度高或明确的TBLC（65例中的39例[60%]），37例（95%）与SLB诊断一致。在65例低置信度或无法分类的TBLC诊断中，有26例（40%），SLB将6例（23%）重新分类为高置信度或明确的MDD诊断。14例（22%）患者因TBLC发生轻中度气道出血。90天的死亡率为2%（65例患者之一），以下急性加重特发性肺纤维化。解释TBLC和SLB之间的协议的组织病理学解释和MDD诊断的高水平。高置信度下TBLC MDD诊断特别可靠，与SLB MDD诊断具有极好的一致性。这些数据支持TBLC在间质性肺病诊断算法中的临床效用。需要进一步研究TBLC的安全性。版权所有（C）2019 Elsevier Ltd.保留所有权利。
Background Transbronchial lung cryobiopsy (TBLC) is a novel technique for sampling lung tissue for interstitial lung disease diagnosis. The aim of this study was to establish the diagnostic accuracy of TBLC compared with surgical lung biopsy (SLB), in the context of increasing use of TBLC in clinical practice as a less invasive biopsy technique.Methods COLDICE was a prospective, multicentre, diagnostic accuracy study investigating diagnostic agreement between TBLC and SLB, across nine Australian tertiary hospitals. Patients with interstitial lung disease aged between 18 and 80 years were eligible for inclusion if they required histopathological evaluation to aid diagnosis, after detailed baseline evaluation. After screening at a centralised multidisciplinary discussion (MDD), patients with interstitial lung disease referred for lung biopsy underwent sequential TBLC and SLB under one anaesthetic. Each tissue sample was assigned a number between 1 and 130, allocated in a computer-generated random sequence. Encoded biopsy samples were then analysed by masked pathologists. At subsequent MDD, de-identified cases were discussed twice with either TBLC or SLB along with clinical and radiological data, in random non-consecutive order. Co-primary endpoints were agreement of histopathological features in TBLC and SLB for patterns of definite or probable usual interstitial pneumonia, indeterminate for usual interstitial pneumonia, and alternative diagnosis; and for agreement of consensus clinical diagnosis using TBLC and SLB at MDD. Concordance and. values were calculated for each primary endpoint. This study is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12615000718549.Findings Between March 15, 2016, and April 15, 2019, we enrolled 65 patients (31 [48%] men, 34 [52%] women; mean age 66.1 years [SD 9.3]; forced vital capacity 83.7% [SD 14.2]; diffusing capacity for carbon monoxide 63.4% [SD 12.8]). TBLC (7.1 mm, SD 1.9) and SLB (46.5 mm, 14.9) samples were each taken from two separate ipsilateral lobes. Histopathological agreement between TBLC and SLB was 70.8% (weighted. 0.70, 95% CI 0.55-0.86); diagnostic agreement at MDD was 76.9% (kappa 0.62, 0.47-0.78). For TBLC with high or definite diagnostic confidence at MDD (39 [60%] of 65 cases), 37 (95%) were concordant with SLB diagnoses. In the 26 (40%) of 65 cases with low-confidence or unclassifiable TBLC diagnoses, SLB reclassified six (23%) to alternative high-confidence or definite MDD diagnoses. Mild-moderate airway bleeding occurred in 14 (22%) patients due to TBLC. The 90-day mortality was 2% (one of 65 patients), following acute exacerbation of idiopathic pulmonary fibrosis.Interpretation High levels of agreement between TBLC and SLB for both histopathological interpretation and MDD diagnoses were shown. The TBLC MDD diagnoses made with high confidence were particularly reliable, showing excellent concordance with SLB MDD diagnoses. These data support the clinical utility of TBLC in interstitial lung disease diagnostic algorithms. Further studies investigating the safety profile of TBLC are needed. Copyright (C) 2019 Elsevier Ltd. All rights reserved.