Robotic versus Electromagnetic Bronchoscopy for Peripheral Pulmonary Lesions: A Randomized Trial (RELIANT).

Although both platforms are routinely used in clinical practice, comparative effectiveness data are lacking.

尽管这两种平台在临床实践中常规使用，但缺乏比较其有效性的数据。

Objectives: We sought to compare the effectiveness of robotic-assisted and electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions.

目的：我们旨在比较机器人辅助和电磁导航支气管镜检查在外周肺病变评估中的有效性。

Methods: In an investigator-initiated, single-center, cluster-randomized noninferiority trial, we assigned patients undergoing diagnostic bronchoscopy for evaluation of a peripheral pulmonary lesion to either robotic-assisted or electromagnetic navigational bronchoscopy.

方法：在一个由研究者发起的单中心、群组随机非劣效试验中，我们将接受诊断性支气管镜检查以评估外周肺病变的患者分配到机器人辅助或电磁导航支气管镜检查组。

The cluster randomization unit was the operating room in which patients were scheduled.

随机分组的单位是患者被安排的手术室。

The primary outcome was the diagnostic yield of the procedure, defined as the proportion of cases yielding lesional tissue.

主要结果是程序的诊断效率，定义为产生病变组织的病例比例。

Secondary and safety outcomes included procedure duration and complications.

次要和安全性结果包括手术持续时间和并发症。

Measurements and Main Results: Among the 411 patients included in the modified intention-to-treatanalysis, lesional tissue was obtained in 158 of 203 (77.8%) patients in the robotic-assisted group and 157 of 208 (75.5%) patients in the electromagnetic group; the P value for noninferiority was 0.007.

测量和主要结果：在纳入修改意向治疗分析的411名患者中，203名患者中有158名（77.8%）在机器人辅助组获得了病变组织，208名患者中有157名（75.5%）在电磁组获得了病变组织；非劣效性的P值为0.007。

The median duration of bronchoscopy was 37 minutes in the robotic-assisted group and 32 minutes in the electromagnetic group (difference, 5 min; 95% confidence interval= 2.0-7.7).

在机器人辅助组中，支气管镜检查的中位持续时间为37分钟，在电磁组中为32分钟（差异，5分钟；95%置信区间=2.0-7.7）。

Pneumothorax occurred in 4 patients in the robotic-assisted group and 6 patients in the electromagnetic group.

机器人辅助组中有4名患者发生气胸，电磁组中有6名患者发生气胸。

Conclusions: In patients undergoing bronchoscopy for the evaluation of a peripheral pulmonary lesion, the diagnostic yield of robotic-assisted bronchoscopy was not inferior to that of electromagnetic navigation bronchoscopy.

结论：对于接受支气管镜检查以评估周围性肺病变的患者，机器人辅助支气管镜的诊断效率不亚于电磁导航支气管镜。

Clinical trial registered with www.clinicaltrials.gov (NCT05705544).

临床试验已在www.clinicaltrials.gov注册（NCT05705544）。