A randomization strategy for a cluster-randomized controlled trial with variable operating room availability.

A single-center, open-label, pragmatic, non-inferiority, cluster randomized controlled trial was conducted to compare the clinical outcomes of two diagnostic bronchoscopy approaches, Platform A and Platform B. A cluster was defined as an operating room (OR) day. The expected allocation ratio at the cluster level was 1:1 between Platform A and Platform B.

2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on Histoplasmosis: Treatment of Asymptomatic Histoplasma Pulmonary Nodules (Histoplasmomas) and Mild or Moderate Acute Pulmonary Histoplasmosis in Adults, Children, and Pregnant People.

As the first part of an update to the clinical practice guideline on the management of histoplasmosis in adults, children, and pregnant people, developed by the Infectious Diseases Society of America, we present 4 updated recommendations. These recommendations span treatment of asymptomatic Histoplasma pulmonary nodules (histoplasmomas), mild acute pulmonary histoplasmosis, and moderate acute pulmonary histoplasmosis. The panel's recommendations are based on evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.

2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on Histoplasmosis: Treatment of Mild or Moderate Acute Pulmonary Histoplasmosis in Adults, Children, and Pregnant People.

This article is part of a larger clinical practice guideline on the management of histoplasmosis in adults, children, and pregnant people, developed by the Infectious Diseases Society of America. In this article, the panel provides recommendations for treatment of mild and moderate acute pulmonary histoplasmosis. The panel's recommendations are based upon evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.

2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on Histoplasmosis: Treatment of Asymptomatic Histoplasma Pulmonary Nodules (Histoplasmomas) in Adults, Children, and Pregnant People.

This paper is part of a larger clinical practice guideline on the management of histoplasmosis in adults, children, and pregnant people, developed by the Infectious Diseases Society of America. In this paper, the panel provides a recommendation for treatment of asymptomatic pulmonary nodules. The panel's recommendation is based upon evidence derived from systematic literature reviews and adheres to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach.

Treatment of Bronchopleural Fistula.

Bronchopleural fistula (BPF) is a challenging clinical condition characterized by an abnormal connection between the bronchial tree and the pleural space. This article aims to provide a thorough review of BPF, encompassing its etiologies, clinical manifestations, diagnostic approaches, and treatment options. Current advancements and future directions in BPF management will also be discussed.

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

Robotic-assisted bronchoscopy has emerged as an alternative to electromagnetic navigational bronchoscopy for patients undergoing bronchoscopic biopsy of a peripheral pulmonary lesion. Although both platforms are routinely used in clinical practice, comparative effectiveness data are lacking. We sought to compare the effectiveness of robotic-assisted and electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions.

Post-Thoracentesis Ultrasound versus Chest Radiography for the Evaluation of Effusion Evacuation and Lung Reexpansion: A Multicenter Study.

Post-thoracentesis chest radiography (CXR) is often used to evaluate the degree of residual fluid after thoracentesis. Whether post-drainage ultrasound examination is comparable to CXR in the evaluation of pleural space evacuation is unknown. How do post-thoracentesis ultrasound and CXR compare in assessing the effectiveness of pleural space evacuation? In this prospective, multicenter study, patients with free-flowing pleural effusions with minimal to no septations requiring thoracentesis were recruited.

Navigational Bronchoscopy or Transthoracic Needle Biopsy for Lung Nodules.

Background: Each year, millions of pulmonary nodules are identified incidentally or through lung cancer screening, and many involve biopsy to distinguish cancer from benign processes. Both navigational bronchoscopy and computed tomography-guided transthoracic needle biopsy are commonly used in patients undergoing biopsies of peripheral pulmonary nodules, but the relative diagnostic accuracy of these two approaches is unclear.

Methods: In this multicenter, randomized, parallel-group, noninferiority trial, we assigned patients with an intermediate-risk or high-risk peripheral pulmonary nodule measuring 10 to 30 mm in diameter to undergo navigational bronchoscopy or transthoracic needle biopsy at seven centers across the United States.

Performance of Lung Cancer Prediction Models for Screening-detected, Incidental, and Biopsied Pulmonary Nodules.

Purpose To evaluate the performance of eight lung cancer prediction models on patient cohorts with screening-detected, incidentally detected, and bronchoscopically biopsied pulmonary nodules. Materials and Methods This study retrospectively evaluated promising predictive models for lung cancer prediction in three clinical settings: lung cancer screening with low-dose CT, incidentally detected pulmonary nodules, and nodules deemed suspicious enough to warrant a biopsy. The area under the receiver operating characteristic curve of eight validated models, including logistic regressions on clinical variables and radiologist nodule characterizations, artificial intelligence (AI) on chest CT scans, longitudinal imaging AI, and multimodal approaches for prediction of lung cancer risk was assessed in nine cohorts ( = 898, 896, 882, 219, 364, 117, 131, 115, 373) from multiple institutions.

Keeping Up With Technological Innovation: The Moral Imperative for Pragmatic Clinical Trials in Interventional Pulmonology.

The advances in minimally invasive lung cancer diagnostics of the last decade have transformed patient care but have also raised important concerns about the regulatory processes used to approve new devices and the best way to generate data to support their use. Disruptive technologies, such as robotic bronchoscopy, have been widely adopted by interventional pulmonologists in the absence of robust data demonstrating improved patient outcomes. Comparative research is needed to inform patient care, but traditional methods of conducting clinical trials in which research teams operate separately from clinical teams are ill-suited to testing the safety and effectiveness of technologies being introduced on the market at unprecedented speed.

Conflicts of Interest in Bronchoscopy Research: Is Self-Reporting Sufficient?

Background: Robotic assisted bronchoscopy has been enthusiastically adopted in the United States and has transformed the treatment of patients with indeterminate pulmonary nodules. Unprecedented industry investments in research, development, and marketing have profoundly affected the bronchoscopy landscape, leading to concerns that conflicts of interest could influence the validity of bronchoscopy studies. Disclosures of conflicts of interest in research are predicated on open and transparent self-reporting.

Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.

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: Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center.

Diagnostic Yield vs Diagnostic Accuracy for Peripheral Lung Biopsy Evaluation: Evidence Supporting a Future Pragmatic End Point.

Background: Diagnostic yield and accuracy endpoints have been used inconsistently in the evaluation of advanced diagnostic bronchoscopy devices and techniques, limiting between-study comparisons. In addition, diagnostic accuracy can be adjudicated only after prolonged clinical follow-up, which delays reporting on the performance of novel devices.

Research Question: Will a conservative diagnostic yield definition result in few false-negative initial results to closely approximate diagnostic accuracy and represent a useful outcome for future studies of diagnostic utility?

Methods: Commonly used definitions of diagnostic yield were applied to a prospective data set of consecutive peripheral pulmonary lesions sampled by navigational bronchoscopy from 2017 to 2019.

Navigational Bronchoscopy versus Computed Tomography-guided Transthoracic Needle Biopsy for the Diagnosis of Indeterminate Lung Nodules: protocol and rationale for the VERITAS multicenter randomized trial.

Background: Lung nodule incidence is increasing. Many nodules require biopsy to discriminate between benign and malignant etiologies. The gold-standard for minimally invasive biopsy, computed tomography-guided transthoracic needle biopsy (CT-TTNB), has never been directly compared to navigational bronchoscopy, a modality which has recently seen rapid technological innovation and is associated with improving diagnostic yield and lower complication rate.

Inter-rater reliability of a novel objective endpoint for benign central airway stenosis interventions: Segmentation-based volume rendering of computed tomography scans.

Objectives: To evaluate the reliability of a novel segmentation-based volume rendering approach for quantification of benign central airway obstruction (BCAO).

Design: A retrospective single-center cohort study.

Setting: Data were ascertained using electronic health records at a tertiary academic medical center in the United States.

Safety and utility of indwelling pleural catheters in lung transplant recipients.

Introduction: The safety and efficacy of indwelling pleural catheters (IPCs) in lung allograft recipients is under-reported.

Methods: We performed a multicenter, retrospective analysis between 1/1/2010 and 6/1/2022 of consecutive IPCs placed in lung transplant recipients. Outcomes included incidence of infectious and non-infectious complications and rate of auto-pleurodesis.

Spray Cryotherapy for Benign Large Airway Stenosis: A Multicenter Retrospective Cohort Study of Safety and Practice Patterns.

Background: Benign airway stenosis (BAS) represents a significant burden on patients, providers, and healthcare systems. Spray cryotherapy (SCT) has been proposed as an adjunctive treatment to reduce BAS recurrence. We sought to examine safety and practice variations of the latest SCT system when used for BAS.

Comparative Treatment Outcomes for Idiopathic Subglottic Stenosis: 5-Year Update.

The North American Airway Collaborative (NoAAC) previously published a 3-year multi-institutional prospective cohort study showing variation in treatment effectiveness between 3 primary surgical techniques for idiopathic subglottic stenosis (iSGS). In this report, we update these findings to include 5 years of data evaluating treatment effectiveness. Patients in the NoAAC cohort were re-enrolled for 2 additional years and followed using the prespecified published protocol.

Shape-Sensing Robotic-Assisted Bronchoscopy vs Digital Tomosynthesis-Corrected Electromagnetic Navigation Bronchoscopy: A Comparative Cohort Study of Diagnostic Performance.

Background: Electromagnetic navigational bronchoscopy has been the dominant bronchoscopic technology for targeting small peripheral lesions and now includes digital tomosynthesis-electromagnetic navigational bronchoscopy (DT-ENB), allowing near-real-time intraprocedural nodule visualization. Shape-sensing robotic-assisted bronchoscopy (ssRAB), with improved catheter stability and articulation recently became available. Although the diagnostic performance of these two methods seems higher than that of legacy systems, data remain limited.