机器人辅助与电磁导航支气管镜检查用于肺病变评估：RELIANT实用随机试验

Robotic versus Electromagnetic Bronchoscopy for Pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.

作者信息

Paez Rafael, Lentz Robert J, Salmon Cristina, Siemann Justin K, Low See-Wei, Casey Jonathan D, Chen Heidi, Chen Sheau-Chiann, Avasarala Sameer, Shojaee Samira, Rickman Otis B, Lindsell Christopher J, Gatto Cheryl L, Rice Todd W, Maldonado Fabien

机构信息

Vanderbilt University Medical Center.

Cleveland Clinic.

出版信息

Res Sq. 2023 Aug 28:rs.3.rs-3222369. doi: 10.21203/rs.3.rs-3222369/v1.

DOI:10.21203/rs.3.rs-3222369/v1

PMID:37693467

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10491348/

Abstract

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

obotic versus lectromagnetic Bronchoscopy for Pulmonary eson ssessme (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 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.

摘要

背景

机器人辅助支气管镜检查最近已成为评估周围型肺病变的电磁导航支气管镜检查的替代方法。虽然机器人辅助支气管镜检查被认为具有若干优势，如学习曲线较平缓，但尚不清楚其诊断效用是否与电磁导航支气管镜检查相当。

方法

机器人与电磁支气管镜用于肺部评估（RELIANT）是一项由研究者发起的、单中心、开放标签、非劣效性、整群随机对照试验，在范德比尔特大学医学中心的两个手术室进行。每个手术室每天上午被分配进行机器人辅助或电磁导航支气管镜检查，每个手术日视为一个整群。在两个手术室之一接受诊断性支气管镜检查以评估周围型肺病变的所有患者均符合条件。调度员、患者和操作医生在每天的分组分配情况被揭晓之前对其不知情，直到每天上午每个手术室的随机分组情况公布。主要终点是诊断率，定义为获取病变组织的病例比例。次要终点和安全性终点包括手术持续时间和手术并发症。入组于2023年3月6日开始，并将持续至累计200个整群，预计到2024年3月完成时约有400名患者入组。