A randomized controlled trial of cryoprobe versus forceps for transbronchial biopsy (FROSTBITE-2): Study protocol for a multi-center pragmatic clinical trial

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2026-03-01 Epub Date: 2026-02-03 DOI:10.1016/j.cct.2026.108251

Jeffrey Thiboutot , Ardian Latifi , Peter Illei , Christopher M. Kapp , Fabien Maldonado , Sonali Sethi , Scott Shofer , Christopher Gilbert , Momen Wahidi , Andrew DeMaio , Ashutosh Sachdeva , David DiBardino , Anil Vachani , Nicholas Pastis , Daniela Molena , Miranda R. Jones , Najib M. Rahman , Gerard Silvestri , Lonny Yarmus

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引用次数: 0

Abstract

Background

Transbronchial biopsy is a common bronchoscopic procedure that is traditionally performed with forceps. However, its diagnostic capability is limited by small specimen size and crush artifact. A 1.1 mm cryoprobe was developed to overcome these limitations utilizing rapid, controlled, freezing to retrieve larger specimens which are extractable through the bronchoscope's working channel. Whether this improves diagnostic yield remains uncertain. The 1.1 mm cryoprobe has not been directly compared to standard capacity forceps in a prospective, randomized fashion.

Methods

This multicenter randomized controlled trial evaluates whether transbronchial biopsy with a 1.1 mm cryoprobe yields superior diagnostic yield compared to standard capacity forceps in adults undergoing transbronchial biopsy for diffuse parenchymal lung disease, parenchymal pulmonary lesions, or lung allografts. Participants will be randomized 1:1 to either biopsy tool, stratified by indication. Primary outcomes include indication-specific and overall diagnostic yield, adjudicated by centralized pathology review. Secondary outcomes include histologic quality metrics and complication rates. This trial is individually powered for each indication-specific primary outcome, and can detect an 11.3% difference in overall diagnostic yield with 250 participants per arm.

Discussion

This trial will provide high-quality evidence to guide transbronchial biopsy tool selection to maximize diagnostic yield. Results of this trial may yield practice changing data for the evaluation of patients with diffuse parenchymal lung disease, parenchymal pulmonary lesions, and lung allografts. Unique design features include the use of a centralized histopathology core to minimize bias and interobserver variability and a pragmatic design to facilitate integration into clinical workflows and optimize recruitment.

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冷冻探针与钳经支气管活检的随机对照试验（FROSTBITE-2）：一项多中心实用临床试验的研究方案。

背景：经支气管活检是一种常见的支气管镜手术，传统上是用镊子进行的。然而，其诊断能力受到样品尺寸小和挤压伪影的限制。为了克服这些限制，开发了1.1 毫米冷冻探头，利用快速、可控的冷冻来检索较大的标本，这些标本可通过支气管镜的工作通道提取。这是否能提高诊断率仍不确定。1.1 mm冷冻探针尚未以前瞻性随机方式直接与标准容量钳进行比较。方法：本多中心随机对照试验评估在弥漫性肺实质疾病、肺实质病变或同种异体肺移植的成人经支气管活检中，与标准容量钳相比，1.1 mm冷冻探针的经支气管活检是否具有更高的诊断率。参与者将按1:1随机分配到活检工具，根据适应症分层。主要结果包括指征特异性和总体诊断率，由集中病理检查决定。次要结局包括组织学质量指标和并发症发生率。该试验对每个特定适应症的主要结局进行单独支持，每组250名参与者可以检测到11.3%的总诊断率差异。讨论：本试验将提供高质量的证据，指导经支气管活检工具的选择，以最大限度地提高诊断率。该试验的结果可能为弥漫性肺实质疾病、肺实质病变和肺同种异体移植患者的评估提供实践改变的数据。独特的设计特点包括使用集中的组织病理学核心，以最大限度地减少偏见和观察者之间的差异，以及实用的设计，以促进整合到临床工作流程和优化招聘。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.