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鞘内冷冻探针经支气管镜透壁活检的安全性和可行性:FROSTBITE 试验。

Safety and Feasibility of a Sheath Cryoprobe for Bronchoscopic Transbronchial Biopsy: The FROSTBITE Trial.

机构信息

Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, Maryland, USA.

Department of Pathology, Johns Hopkins University, Baltimore, Maryland, USA.

出版信息

Respiration. 2022;101(12):1131-1138. doi: 10.1159/000526876. Epub 2022 Oct 20.

DOI:10.1159/000526876
PMID:36265451
Abstract

BACKGROUND

Bronchoscopic lung biopsy is typically performed using transbronchial forceps. However, this method is limited by small sample size and presence of crush artifact. Cryobiopsy offers the potential to overcome these limitations with larger artifact-free samples but has not been widely adopted due to concerns over increased rates of bleeding and pneumothorax. A new, smaller 1.1-mm cryoprobe has been developed that operates in a similar fashion to forceps, though the safety profile of this cryoprobe has not yet been prospectively studied.

OBJECTIVE

The aim of this study was to investigate the safety of transbronchial biopsy using a novel 1.1-mm cryoprobe.

METHODS

This prospective, single-arm study enrolled patients referred for transbronchial biopsy. All procedures were performed using the 1.1-mm cryoprobe with oversheath. The primary outcome was the composite of significant complications related to the cryobiopsy procedure (bleeding Grade ≥3, pneumothorax Grade ≥2, and respiratory failure). Bleeding and pneumothorax were graded according to previously published scales.

RESULTS

Fifty participants from two academic medical centers underwent transbronchial cryobiopsy. Indications for biopsy included evaluation of lung transplant allograft (50%), diffuse lung disease (44%), and pulmonary parenchymal lesion (6%). There were two pneumothoraces (4%), neither of which required aspiration or chest tube placement. There were no Grade 3 or 4 bleeding events. Mild bleeding (Grade ≤2) was observed in 25 cases (50%). No complications occurred that met the a priori primary outcome of bleeding Grade ≥3, pneumothorax Grade ≥2, and respiratory failure.

CONCLUSIONS

Transbronchial cryobiopsy using a 1.1-mm cryoprobe is feasible with an acceptable safety profile.

摘要

背景

支气管镜肺活检通常使用经支气管活检钳进行。然而,这种方法受到样本量小和挤压伪影的限制。冷冻活检具有提供更大无伪影样本的潜力,但由于担心出血和气胸发生率增加,尚未广泛采用。已经开发出一种新的、较小的 1.1mm 冷冻探针,其操作方式与活检钳类似,但这种冷冻探针的安全性尚未经过前瞻性研究。

目的

本研究旨在探讨使用新型 1.1mm 冷冻探针进行经支气管活检的安全性。

方法

这项前瞻性、单臂研究纳入了因经支气管活检而转诊的患者。所有操作均使用带护套的 1.1mm 冷冻探针进行。主要结局是与冷冻活检程序相关的严重并发症的综合结果(出血分级≥3、气胸分级≥2 和呼吸衰竭)。出血和气胸根据先前发表的量表进行分级。

结果

来自两个学术医疗中心的 50 名参与者接受了经支气管冷冻活检。活检的指征包括肺移植供体评估(50%)、弥漫性肺疾病(44%)和肺实质病变(6%)。发生了 2 例气胸(4%),均无需抽吸或放置胸管。没有 3 级或 4 级出血事件。25 例(50%)观察到轻度出血(分级≤2)。没有发生符合预先设定的主要结局的严重出血(分级≥3)、气胸(分级≥2)和呼吸衰竭的并发症。

结论

使用 1.1mm 冷冻探针进行经支气管冷冻活检是可行的,具有可接受的安全性。

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