Department of Haematology, Oncology, Rheumatology, Immunology and Pulmology, Eberhard Karls University, Otfried-Mueller-Str. 10, 70771, Tübingen, Germany.
Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg (TLRCH, German Center for Lung Research (DZL), Heidelberg, Germany.
Respir Res. 2019 Jul 5;20(1):140. doi: 10.1186/s12931-019-1091-1.
Bronchoscopic cryobiopsy is a new method of bronchoscopic tissue sampling in interstitial lung disease. In case of transbronchial biopsies, the resultant tissue samples are of high quality, and the lung parenchyma seen in the samples is adequate for a histological diagnosis in most cases. Bleeding after transbronchial biopsy is the most important procedure- associated complication and may be life threatening. This study addresses the risk of bleeding of transbronchial cryobiopsy.
In this prospective, randomized, controlled multicentre study 359 patients with interstitial lung disease requiring diagnostic bronchoscopic tissue sampling were included. Both conventional transbronchial forceps biopsy and transbronchial cryobiopsy were undertaken in each patient. The sequence of the procedures was randomized. Bleeding severity was evaluated semi-quantitatively as "no bleeding", "mild" (suction alone), "moderate" (additional intervention) or "severe" (prolonged monitoring necessary or fatal outcome), for each intervention.
In 359 patients atotal of 1160 cryobiopsies and 1302 forceps biopsies were performed. Bleeding was observed after forceps biopsy in 173 patients (48.2%) and after cryobiopsy in 261 patients (72.7%). Bleeding was significantly greater in the cryobiopsy group (cryobiopsy/forceps biopsy: no bleeding 27.3%/51.8%; mild 56.5%/44.0%; moderate 15.0%/4.2%; severe 1.2%/0%; p < 0.001). The rate of clinically relevant bleeding (moderate or severe) was higher after the cryobiopsy procedures compared to the forceps biopsies (16.2% vs. 4.2%, p < 0.05). No fatal bleeding complications occurred.
Compared to transbronchial forceps biopsy, transbronchial cryobiopsy was associated with an increased risk of bleeding which is of clinical relevance. Therefore training and additional precautions for bleeding control should be considered.
The study was registered with clinicaltrials.gov ( NCT01894113 ).
支气管镜冷冻活检是一种新的间质性肺疾病支气管镜组织取样方法。在经支气管活检中，所获得的组织样本质量高，且在大多数情况下，样本中的肺实质足以进行组织学诊断。经支气管活检后出血是最重要的与操作相关的并发症，可能危及生命。本研究旨在探讨经支气管冷冻活检出血的风险。
本前瞻性、随机、对照多中心研究纳入 359 例需要诊断性支气管镜组织取样的间质性肺病患者。每位患者均接受常规经支气管活检钳活检和经支气管冷冻活检。操作顺序随机化。每一种干预措施的出血严重程度均采用半定量方法评估为“无出血”、“轻度”（仅抽吸）、“中度”（需附加干预）或“重度”（需延长监测或有致命后果）。
在 359 例患者中，共进行了 1160 次冷冻活检和 1302 次活检钳活检。活检钳活检后有 173 例（48.2%）患者出现出血，冷冻活检后有 261 例（72.7%）患者出现出血。冷冻活检组的出血明显更多（冷冻活检/活检钳活检：无出血 27.3%/51.8%；轻度 56.5%/44.0%；中度 15.0%/4.2%；重度 1.2%/0%；p<0.001）。冷冻活检组较活检钳活检组发生临床相关出血（中重度）的比例更高（16.2% vs. 4.2%，p<0.05）。无致命性出血并发症发生。
与经支气管活检钳活检相比，经支气管冷冻活检出血风险增加，且具有临床相关性。因此，应考虑培训和额外的出血控制预防措施。
本研究在 clinicaltrials.gov 上注册（NCT01894113）。
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