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Background and Objective: Transbronchial sampling of peripheral pulmonary lesions (PPLs) is routinely performed under fluoroscopy. However, advanced ancillary techniques have become available, such as virtual bronchoscopic navigation (VBN) and radial endobronchial ultrasound with a guide sheath (rEBUS‐GS). This study was performed to determine whether the diagnostic utility of VBN and rEBUS with a GS is similar with or without fluoroscopy. Methods: This multicenter non‐inferiority trial randomized patients to a VBN‐rEBUS‐GS with or without fluoroscopy group at three centres. The primary endpoint was the diagnostic yield. The secondary endpoints were the time for rEBUS, GS, and the total operation. Complications were also recorded. Results: Four hundred and ninety‐six subjects were assessed and 426 subjects were included in the analysis (212 in non‐fluoroscopy‐guided‐group and 214 in fluoroscopy‐guided‐group). The diagnostic yield in the non‐fluoroscopy‐guided‐group (84.0%) was not inferior to that in the fluoroscopy‐guided‐group (84.6%), with a diagnostic difference of −0.6% (95% CI: −6.4%, 5.2%). Multivariable analysis confirmed that bronchus sign and lesion nature were valuable diagnostic predictors in non‐fluoroscopy‐guided‐group. The non‐fluoroscopy‐guided‐group had shorter rEBUS, GS, and total operation time. No severe complications occurred in either group. Conclusion: Transbronchial diagnosis of PPLs suspicious of malignancy and presence of a bronchus leading to or adjacent to lesions using VBN‐rEBUS‐GS without fluoroscopy is a safe and effective method that is non‐inferior to VBN‐rEBUS‐GS with fluoroscopy. Bronchus leading to lesions and malignant nature are associated with high diagnostic yield in VBN‐rEBUS‐GS without fluoroscopy for the diagnosis of PPLs. [ABSTRACT FROM AUTHOR]

Rationale: Endobronchial ultrasound (EBUS) combined with a guide sheath (GS) as an instrument for confirming the proximity of the bronchoscope and its relationship to the lesion can increase the diagnostic yield when conducting transbronchial lung biopsy of peripheral pulmonary nodules (PPNs). A novel electromagnetic navigational bronchoscopy (ENB) system comprising a thinner locatable sensor probe as a guidance instrument was developed to be suitable for a thin bronchoscope with a working channel 2 mm in diameter. The diagnostic efficacy of EBUS-GS with or without this ENB system has not been confirmed. Objectives: To compare the diagnostic value and safety of EBUS-GS with or without the ENB system for diagnosing PPNs. Methods: A prospective, multicenter, randomized controlled clinical trial was designed and conducted at three centers. Patients with PPNs suspected to be malignant were enrolled and randomly assigned to the ENB-EBUS-GS group or the EBUS-GS group. The primary endpoint was the diagnostic yield in each group. The secondary endpoint was the procedural time and other factors affecting diagnostic yield. The safety endpoint was procedural complications. Results: Four hundred participants were enrolled from July 2018 to October 2019, and 385 patients were analyzed, 193 in the ENB-EBUS-GS group and 192 in the EBUS-GS group. The mean nodule size was 21.7 ± 5.3 mm. The diagnostic yields were 82.9% (95% confidence interval [CI], 77.6-88.2%) in the ENB-EBUS-GS group and 73.4% (95% CI, 67.2-79.7%) in the EBUS-GS group. The difference between the two groups was 9.5% (95% CI, 2.6-16.3%), with an adjusted difference of 9.0% (95% CI, 2.3-15.8%) after adjusting for the stratification factors and center. The time to find lesions in the ENB-EBUS-GS group was shorter than in the EBUS-GS group (213.2 ± 145.6 vs. 264.8 ± 189.5 s; P = 0.003). Intraoperative hemorrhage occurred 3.6% of subjects in the ENB-EBUS-GS group and 3.1% in the EBUS-GS group, without significant differences between the two groups. Conclusions: The novel ENB system combined with EBUS-GS demonstrated improved ability to locate PPNs, achieving a high diagnostic yield for PPNs compared with EBUS-GS alone in a safe and efficient procedure. Clinical trial registered with www.clinicaltrials.gov (NCT03569306). [ABSTRACT FROM AUTHOR]

Background: Endobronchial ultrasound (EBUS) imaging is valuable in diagnosing intrathoracic lymph nodes (LNs), but there has been little analysis of multimodal imaging. This study aimed to comprehensively compare the diagnostic performance of single and multimodal combinations of EBUS imaging in differentiating benign and malignant intrathoracic LNs. Methods: Subjects from July 2018 to June 2019 were consecutively enrolled in the model group and July 2019 to August 2019 in the validation group. Sonographic features of three EBUS modes were analysed in the model group for the identification of malignant LNs from benign LNs. The validation group was used to verify the diagnostic efficiency of single and multimodal diagnostic methods built in the model group. Results: 373 LNs (215 malignant and 158 benign) from 335 subjects and 138 LNs (79 malignant and 59 benign) from 116 subjects were analysed in the model and validation groups, respectively. For single mode, elastography had the best diagnostic value, followed by grayscale and Doppler. The corresponding accuracies in the validation group were 83.3%, 76.8%, and 71.0%, respectively. Grayscale with elastography had the best diagnostic efficiency of multimodal methods. When at least two of the three features (absence of central hilar structure, heterogeneity, and qualitative elastography score 4–5) were positive, the sensitivity, specificity, and accuracy in the validation group were 88.6%, 78.0%, and 84.1%, respectively. Conclusions: In both model and validation groups, elastography performed the best in single EBUS modes, as well as grayscale combined with elastography in multimodal imaging. Elastography alone or combined with grayscale are feasible to help predict intrathoracic benign and malignant LNs. [ABSTRACT FROM AUTHOR]

Background: Transbronchial lung biopsy (TBLB) is usually performed to obtain a definitive diagnosis for peripheral pulmonary lesions (PPLs). Ultrathin bronchoscopy combined with virtual bronchoscopic navigation (VBN) and radial endobronchial ultrasound (R‐EBUS) are generally considered appropriate diagnostic methods for PPLs; however, they have not yet been explored in combination with fluoroscopy. Therefore, the present prospective randomized controlled trial determined the role of fluoroscopy in ultrathin bronchoscopy combined with VBN and R‐EBUS for the diagnosis of PPLs. Methods: Patients with potentially malignant PPLs were enrolled in the study and randomized into fluoroscopy or nonfluoroscopy groups. In both groups, a 3.0‐mm outer and 1.7‐mm internal diameter ultrathin bronchoscope was used for transbronchial lung biopsy combined with R‐EBUS and VBN. In addition, the fluoroscopy group (FG) underwent fluoroscopy, while the nonfluoroscopy group (NFG) did not. Results: A total of 126 patients were enrolled and randomized in the study. Among them, 120 patients (60 in the NFG and 60 in the FG) were analyzed. The mean lesion sizes were 26.3 ± 11.4 mm and 29.0 ± 11.3 mm in the NFG and FG, respectively. The diagnostic yield was 73.3% (44/60) in the NFG and 81.7% (49/60) in the FG without statistically significant difference (p = 0.38). No obvious complications occurred in either group. Conclusions: Ultrathin bronchoscope combined with VBN and R‐EBUS without fluoroscopy is a feasible and safe diagnostic method for PPLs. [ABSTRACT FROM AUTHOR]

Background: Endoscopic ultrasound (EBUS) strain elastography can diagnose intrathoracic benign and malignant lymph nodes (LNs) by reflecting the relative stiffness of tissues. Due to strong subjectivity, it is difficult to give full play to the diagnostic efficiency of strain elastography. This study aims to use machine learning to automatically select high-quality and stable representative images from EBUS strain elastography videos. Methods: LNs with qualified strain elastography videos from June 2019 to November 2019 were enrolled in the training and validation sets randomly at a quantity ratio of 3:1 to train an automatic image selection model using machine learning algorithm. The strain elastography videos in December 2019 were used as the test set, from which three representative images were selected for each LN by the model. Meanwhile, three experts and three trainees selected one representative image severally for each LN on the test set. Qualitative grading score and four quantitative methods were used to evaluate images above to assess the performance of the automatic image selection model. Results: A total of 415 LNs were included in the training and validation sets and 91 LNs in the test set. Result of the qualitative grading score showed that there was no statistical difference between the three images selected by the machine learning model. Coefficient of variation (CV) values of the four quantitative methods in the machine learning group were all lower than the corresponding CV values in the expert and trainee groups, which demonstrated great stability of the machine learning model. Diagnostic performance analysis on the four quantitative methods showed that the diagnostic accuracies were range from 70.33% to 73.63% in the trainee group, 78.02% to 83.52% in the machine learning group, and 80.22% to 82.42% in the expert group. Moreover, there were no statistical differences in corresponding mean values of the four quantitative methods between the machine learning and expert groups (p >0.05). Conclusion: The automatic image selection model established in this study can help select stable and high-quality representative images from EBUS strain elastography videos, which has great potential in the diagnosis of intrathoracic LNs. [ABSTRACT FROM AUTHOR]

Background: Endobronchial ultrasound (EBUS) elastography is a new imaging procedure for describing the elasticity of intrathoracic lesions and providing important additional diagnostic information. Objectives: The aim of this study was to utilize the feasibility of qualitative and quantitative methods to evaluate the ability of EBUS elastography to differentiate between benign and malignant mediastinal and hilar lymph nodes (LNs) during EBUS-guided transbronchial needle aspiration (EBUS-TBNA). Methods: Patients with enlarged intrathoracic LNs required for EBUS-TBNA examination at a clinical center for thoracic medicine from January 2014 to April 2014 were prospectively enrolled. EBUS sonographic characteristics on B-mode, vascular patterns and elastography, EBUS-TBNA procedures, pathological findings, and microbiological results were recorded. Further-more, elastographic patterns (qualitative method) and the mean gray value inside the region of interest (quantitative method) were analyzed. Both methods were compared with a definitive diagnosis of the involved LNs. Results: Fifty-six patients including 68 LNs (33 benign and 35 malignant nodes) were prospectively enrolled into this study and retrospectively analyzed. Using qualitative and quantitative methods, we were able to differentiate between benign and malignant LNs with high sensitivity, specificity, positive and negative predictive values, and accuracy (85.71, 81.82, 83.33, 84.38, and 83.82% vs. 91.43, 72.73, 78.05, 88.89, and 82.35%, respectively). Conclusions: EBUS elastography is potentially capable of further differentiating between benign and malignant LNs. These proposed qualitative and quantitative methods might be useful tools for describing EBUS elastography during EBUS-TBNA. [ABSTRACT FROM AUTHOR]

Endobronchial ultrasound (EBUS) features have been found to be a useful tool in differentiating malignant from benign lymph nodes, but the use of these features to distinguish benign intrathoracic lymphadenopathies, including tuberculosis, sarcoidosis and reactive lymphadenitis, has not been established. The goal of this study was to evaluate the use of EBUS features in predicting tuberculosis, sarcoidosis, and non-specific inflammation. One hundred eighty-eight patients with suspected benign lymphadenopathy were included in the study. The EBUS features studied were short axis, shape, calcification, central hilar structure, necrosis sign, margins, echogenicity, clustered formation and vascular patterns. The sonographic findings were confirmed by clinicopathologic results. EBUS-Guided transbronchial needle aspiration was performed on 452 lymph nodes. Thirty-seven tuberculous nodes, 193 sarcoid nodes and 150 reactive nodes were retrospectively analyzed. Excluded were 72 nodes. Multivariate analysis revealed that presence of the necrosis sign and absence of the clustered formation are independent factors predictive of tuberculous nodes. Short axis >1 cm, absence of central hilar structure, distinct margins, presence of clustered formation and non-hilar perfusion were predictive of sarcoid nodes. Presence of central hilar structure, absence of clustered formation and vascular pattern (hilar perfusion or avascularity) were predictive of reactive lymphadenitis. The sum score model of these combined predictive factors indicated that the best diagnostic accuracies for predicting tuberculous nodes, sarcoid nodes and reactive lymphadenitis were 77.1%, 89.2% and 87.1%, respectively. Sonographic features could be helpful in differentiating the type of benign intrathoracic lymphadenopathy during EBUS examination. [ABSTRACT FROM AUTHOR]