The Diagnostic Yield of Cone Beam CT Combined With Radial-Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Nodules

Michael V. Brown , Arash Badiei , Matthew Arnold , Hubertus Jersmann , Thomas Sullivan , David Fielding , Phan Nguyen
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Abstract

Background

Identification of peripheral pulmonary nodules (PPNs) is becoming increasingly common with modern imaging and lung cancer screening programs. Navigational bronchoscopy has been developed to augment the diagnostic yield of sampling these nodules. Cone beam CT (CBCT) scan is one navigational tool which can be used alongside the historical criterion standard of fluoroscopy and radial endobronchial ultrasound (r-EBUS).

Research Question

What is the diagnostic yield and safety profile of combining CBCT scan with r-EBUS for the diagnosis of PPNs?

Study Design and Methods

Embase, PubMed, and Cochrane Central Register of Controlled Trials were searched in March 2023. Eligible studies used CBCT scan with r-EBUS as the primary navigation technique. The primary outcome, diagnostic yield, was analyzed using random effects meta-analysis. Additional subgroup analysis was based on the use of additional navigational technologies. Risk of bias was assessed using the Critical Appraisal Skills Programme tool for diagnostic studies. The Grading of Recommendations Assessment, Development, and Evaluation tool was used to assess the quality of outcomes.

Results

Fourteen studies (865 patients and 882 lesions) were included. The risk of bias was significant as assessed using the Critical Appraisal Skills Programme tool, which identified multiple confounders. The pooled diagnostic yield of combined CBCT scan and r-EBUS-guided biopsy for the diagnosis of PPNs was 80% (95% CI, 76%-84%). Subgroup analysis of diagnostic yield for CBCT scan and r-EBUS alone was 80% (95% CI, 76%-83%). The diagnostic yield of CBCT scan and r-EBUS combined with additional navigational technology (electromagnetic navigational bronchoscopy, virtual bronchoscopic navigation, and robotic-assisted bronchoscopy) was 80% (95% CI, 73%-87%). The quality of outcomes was assessed as low to very low using the Grading of Recommendations Assessment, Development, and Evaluation tool. There was a 2.01% pneumothorax rate and 1.08% bleeding rate. Although heterogeneously reported, the total radiation dose was between 19.59 and 85.9 Gy.cm2, resulting in an approximate effective dose range of 3.1 to 13.8 mSv.

Interpretation

CBCT scan and r-EBUS for the diagnosis of PPNs has a high diagnostic yield and acceptable safety profile. Studies showed moderate heterogeneity with significant bias; hence, generalizability of the study is limited and further prospective trials are required.

Clinical Trial Registration

PROSPERO; No.: CRD42023410221; URL: https://www.crd.york.ac.uk/prospero/.

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锥形束计算机断层扫描结合径向支气管内超声诊断周围肺结节的诊断率:系统回顾与元分析
背景在现代影像学和肺癌筛查项目中,外周肺结节(PPN)的识别越来越普遍。为了提高这些结节取样的诊断率,人们开发了导航支气管镜。锥形束 CT(CBCT)扫描是一种导航工具,可与透视和径向支气管内超声(r-EBUS)这一历史标准同时使用。研究问题将 CBCT 扫描与 r-EBUS 结合用于诊断 PPNs 的诊断率和安全性如何?符合条件的研究将 CBCT 扫描和 r-EBUS 作为主要导航技术。采用随机效应荟萃分析法对主要结果(诊断率)进行了分析。另外还根据其他导航技术的使用情况进行了分组分析。偏倚风险采用诊断研究的 "批判性评估技能计划 "工具进行评估。结果纳入了14项研究(865名患者和882个病灶)。使用 "批判性评估技能计划 "工具对偏倚风险进行了评估,发现了多种混杂因素。CBCT扫描和r-EBUS引导活检对PPNs诊断的综合诊断率为80%(95% CI,76%-84%)。单独进行CBCT扫描和r-EBUS的亚组分析诊断率为80%(95% CI,76%-83%)。CBCT 扫描和 r-EBUS 结合其他导航技术(电磁导航支气管镜、虚拟支气管镜导航和机器人辅助支气管镜)的诊断率为 80%(95% CI,73%-87%)。采用建议分级评估、开发和评价工具,结果质量被评为低至很低。气胸发生率为 2.01%,出血发生率为 1.08%。尽管报道不一,但总辐射剂量在 19.59 至 85.9 Gy.cm2 之间,因此有效剂量范围约为 3.1 至 13.8 mSv。研究显示存在中度异质性和明显偏倚;因此,研究的推广性有限,需要进一步的前瞻性试验。临床试验注册PROSPERO;编号:CRD42023410221;网址:https://www.crd.york.ac.uk/prospero/.
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