Supplementary Material for: Accuracy and Predictors of Success of EUS-B-FNA in the Diagnosis of Pulmonary Malignant Lesions: A Prospective Multicenter Italian Study

Background: The role of endoscopic ultrasound with bronchoscope fine-needle aspiration (EUS-B-FNA) in the diagnosis of suspected malignant pulmonary lesions adjacent to the esophagus has been poorly investigated. The aim of the present study was to assess the accuracy of EUS-B-FNA for the diagnosis and molecular profiling of paraesophageal pulmonary lesions, as well as its predictors of success. Materials and Methods: Patients who underwent EUS-B-FNA for the diagnosis of paraesophageal lesions were consecutively enrolled in four Italian centers. Demographic, clinical, procedural, pathological, and molecular characteristics of the malignant samples were collected. The primary outcome was the diagnostic accuracy for pulmonary malignancies. Secondary outcomes were diagnostic yield and predictors of success for diagnosis and molecular profiling. Results: 107 adult patients (60 [56.1%] males; median (interquartile range) age: 69 [60–70] years) were enrolled. The diagnostic accuracy of EUS-B-FNA was 95.3% in the overall cohort and 95.2% in the 99 patients with a final diagnosis of malignancy. Neither clinical nor procedural variables significantly affected the diagnostic accuracy, whereas rapid on-site evaluation (ROSE), performed by pathologists or trained pulmonologists, was a strong predictor for a complete molecular profiling (OR [95% CI]: 12.9 [1.2–137.4]; p value: 0.03). Conclusion: EUS-B-FNA is a safe and accurate method for the diagnosis of paraesophageal pulmonary lesions. The presence of ROSE is relevant for a complete molecular profiling in this selected cohort of patients with advanced lung cancer.背景：经支气管镜内镜超声引导下细针抽吸术（endoscopic ultrasound with bronchoscope fine-needle aspiration, EUS-B-FNA）在食管旁疑似恶性肺部病变诊断中的应用价值尚未得到充分研究。 本研究旨在评估EUS-B-FNA用于食管旁肺部病变诊断及分子分型的准确性，以及其操作成功的预测因素。 材料与方法：在意大利四家医学中心连续纳入因诊断食管旁病变而行EUS-B-FNA的患者。 收集恶性样本的人口学、临床、操作、病理及分子特征。 本研究的主要结局指标为肺部恶性肿瘤的诊断准确性，次要结局指标为诊断检出率以及诊断与分子分型的操作成功预测因素。 结果：共纳入107例成年患者，其中男性60例（占比56.1%），年龄中位数（四分位间距）为69[60~70]岁。 整体队列中EUS-B-FNA的诊断准确性为95.3%，在最终确诊为恶性肿瘤的99例患者中，诊断准确性为95.2%。 临床及操作变量均未对诊断准确性产生显著影响；而由病理科医师或经过培训的肺科医师实施的现场快速评估（rapid on-site evaluation, ROSE）是实现完整分子分型的强预测因素（优势比[95%置信区间]：12.9[1.2~137.4]；P值：0.03）。 结论：EUS-B-FNA是一种安全且准确的食管旁肺部病变诊断方法。 在本研究纳入的晚期肺癌患者队列中，现场快速评估（ROSE）的应用与完整分子分型的实现密切相关。