机器人与电磁支气管镜用于肺部病变评估：RELIANT 实用随机试验。
Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.
机构信息
Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN, USA.
出版信息
Trials. 2024 Jan 19;25(1):66. doi: 10.1186/s13063-023-07863-3.
BACKGROUND
Robotic-assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic-assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy.
METHODS
Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center. Each operating room (OR) is assigned to either robotic-assisted or electromagnetic navigational bronchoscopy each morning, with each OR day considered one cluster. All patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion in one of the two operating rooms are eligible. Schedulers, patients, and proceduralists are blinded to daily group allocations until randomization is revealed for each operating room each morning. The primary endpoint is the diagnostic yield defined as the proportion of cases yielding lesional tissue. Secondary and safety endpoints include procedure duration and procedural complications. Enrolment began on March 6, 2023, and will continue until 202 clusters have been accrued, with expected enrolment of approximately 400 patients by the time of completion in March of 2024.
DISCUSSION
RELIANT is a pragmatic randomized controlled trial that will compare the diagnostic yield of the two most commonly used bronchoscopic approaches for sampling peripheral pulmonary lesions. This will be the first known cluster randomized pragmatic trial in the interventional pulmonology field and the first randomized controlled trial of robotic-assisted bronchoscopy.
TRIAL REGISTRATION
ClinicalTrials.gov registration (NCT05705544) on January 30, 2023.
背景
机器人辅助支气管镜检查最近已成为电磁导航支气管镜检查的替代方法，用于评估周围性肺部病变。虽然机器人辅助支气管镜检查具有易于学习的优势，但它是否具有与电磁导航支气管镜检查相当的诊断效用尚不清楚。
方法
这是一项由研究者发起的、单中心、开放标签、非劣效性、集群随机对照试验，在范德比尔特大学医学中心的两个手术室进行。每个手术室（OR）每天上午被分配给机器人辅助或电磁导航支气管镜检查，每个 OR 日被视为一个集群。在两个手术室之一接受诊断性支气管镜检查以评估周围性肺部病变的所有患者均符合条件。调度员、患者和操作医师在每天上午揭示每个手术室的分组分配之前对每日分组分配保持盲态。主要终点是诊断产量定义为产生病变组织的病例比例。次要和安全性终点包括手术持续时间和手术并发症。招募于 2023 年 3 月 6 日开始，将继续进行，直到累积了 200 个集群，预计在 2024 年 3 月完成时将招募大约 400 名患者。
讨论
RELIANT 是一项实用的随机对照试验，将比较两种最常用于采样周围性肺部病变的支气管镜检查方法的诊断产量。这将是介入性肺病学领域首个已知的集群随机实用试验，也是首个机器人辅助支气管镜检查的随机对照试验。
试验注册
2023 年 1 月 30 日在 ClinicalTrials.gov 注册（NCT05705544）。
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