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Background Traditional bronchoscopy provides limited approach to peripheral nodules. Shape-sensing robotic-assisted bronchoscopy (SSRAB, Ion™ Endoluminal System) is a new tool for minimally invasive peripheral nodule biopsy. We sought to answer the research question: Does SSRAB facilitate sampling of pulmonary nodules during bronchoscopists’ initial experience? Methods The lead-in stage of a multicenter, single-arm, prospective evaluation of the Ion Endoluminal System (PRECIsE) is described. Enrolled subjects ≥ 18 years old had recent computed tomography evidence of one or more solid or semi-solid pulmonary nodules ≥ 1.0 to ≤ 3.5 cm in greatest dimension and in any part of the lung. Subjects were followed at 10- and 30-days post-procedure. This stage provided investigators and staff their first human experience with the SSRAB system; safety and procedure outcomes were analyzed descriptively. Neither diagnostic yield nor sensitivity for malignancy were assessed in this stage. Categorical variables are summarized by percentage; continuous variables are summarized by median/interquartile range (IQR). Results Sixty subjects were enrolled across 6 hospitals; 67 nodules were targeted for biopsy. Median axial, coronal and sagittal diameters were < 18 mm with a largest cardinal diameter of 20.0 mm. Most nodules were extraluminal and distance from the outer edge of the nodule to the pleura or nearest fissure was 4.0 mm (IQR: 0.0, 15.0). Median bronchial generation count to the target location was 7.0 (IQR: 6.0, 8.0). Procedure duration (catheter-in to catheter-out) was 66.5 min (IQR: 50.0, 85.5). Distance from the catheter tip to the closest edge of the virtual nodule was 7.0 mm (IQR: 2.0, 12.0). Biopsy completion was 97.0%. No pneumothorax or airway bleeding of any grade was reported. Conclusions Bronchoscopists leveraged the Ion SSRAB’s functionality to drive the catheter safely in close proximity of the virtual target and to obtain biopsies. This initial, multicenter experience is encouraging, suggesting that SSRAB may play a role in the management of pulmonary nodules. Clinical Trial Registration identifier and date NCT03893539; 28/03/2019.

Abstract Rationale Data about the influence of the type of sedation on yield, complications, and tolerance of endobronchial ultrasound–guided transbronchial needle aspiration (EBUS-TBNA) are based mostly on retrospective studies and are largely inconsistent. Objectives To determine whether the type of sedation influences the diagnostic yield of EBUS-TBNA, its complication rates, and patient tolerance. Methods Patients referred for EBUS-TBNA were randomized (1:1) to undergo this procedure under general anesthesia (GA) or moderate sedation (MS). Pathologists were blinded to group allocation. Measurements and Main Results The main outcome was “diagnostic yield,” defined as the percentage of patients for whom EBUS-TBNA rendered a specific diagnosis. One hundred and forty-nine patients underwent EBUS-TBNA, 75 under GA and 74 under MS. Demographic and baseline clinical characteristics were well balanced. Two hundred and thirty-six lymph nodes (LNs) and six masses were sampled in the GA group (average, 3.2 ± 1.9 sites/patient), and 200 LNs and six masses in the MS group (average, 2.8 ± 1.5 sites/patient) (P = 0.199). The diagnostic yield was 70.7% (53 of 75) and 68.9% (51 of 74) for the GA group and MS group, respectively (P = 0.816). The sensitivity was 98.2% in the GA group (confidence interval, 97–100%) and 98.1% in the MS group (confidence interval, 97–100%) (P = 0.979). EBUS was completed in all patients in the GA group, and in 69 patients (93.3%) in the MS group (P = 0.028). There were no major complications or escalation of care in either group. Minor complications were more common in the MS group (29.6 vs. 5.3%) (P < 0.001). Most patients stated they “definitely would” undergo this procedure again in both groups (P = 0.355). Conclusions EBUS-TBNA performed under MS results in comparable diagnostic yield, rate of major complications, and patient tolerance as under GA. Future prospective multicenter studies are required to corroborate our findings. Clinical trial registered with www.clinicaltrials.gov (NCT 01430962).

Peripheral bronchoscopy with the use of thin/ultrathin bronchoscopes and radial-probe endobronchial ultrasound (RP-EBUS) has been associated with a fair diagnostic yield. Mobile cone-beam CT (m-CBCT) could potentially improve the performance of these readily available technologies. We retrospectively reviewed the records of patients undergoing bronchoscopy for peripheral lung lesions with thin/ultrathin scope, RP-EBUS, and m-CBCT guidance. We studied the performance (diagnostic yield and sensitivity for malignancy) and safety (complications, radiation exposure) of this combined approach. A total of 51 patients were studied. The mean target size was 2.6 cm (SD, 1.3 cm) and the mean distance to the pleura was 1.5 cm (SD, 1.4 cm). The diagnostic yield was 78.4% (95 CI, 67.1–89.7%), and the sensitivity for malignancy was 77.4% (95 CI, 62.7–92.1%). The only complication was one pneumothorax. The median fluoroscopy time was 11.2 min (range, 2.9–42.1) and the median number of CT spins was 1 (range, 1–5). The mean Dose Area Product from the total exposure was 41.92 Gy·cm2 (SD, 11.35 Gy·cm2). Mobile CBCT guidance may increase the performance of thin/ultrathin bronchoscopy for peripheral lung lesions in a safe manner. Further prospective studies are needed to corroborate these findings.

Background: Computed tomography to body divergence (CTBD) is one of the main barriers to bronchoscopic techniques for the diagnosis of peripherally located lung nodules. Cone-beam CT (CBCT) guidance is being rapidly adopted to correct for this phenomenon and to potentially increase diagnostic outcomes. In this trial, we hypothesized that the addition of mobile CBCT (m-CBCT) could improve the rate of tool in lesion (TIL) and the diagnostic yield of shape-sensing robotic-assisted bronchoscopy (SS-RAB). Methods: This was a prospective, single-arm study, which enrolled patients with peripheral lung nodules of 1–3 cm and compared the rate of TIL and the diagnostic yield of SS-RAB alone and combined with mCBCT. Results: A total of 67 subjects were enrolled, the median nodule size was 1.7 cm (range, 0.9–3 cm). TIL was achieved in 23 patients (34.3%) with SS-RAB alone, and 66 patients (98.6%) with the addition of mCBCT (p < 0.0001). The diagnostic yield of SS-RAB alone was 29.9% (95% CI, 29.3–42.3%) and it was 86.6% (95% CI, 76–93.7%) with the addition of mCBCT (p < 0.0001). There were no pneumothoraxes or any bronchoscopy-related complications, and the median total dose–area product (DAP) was 50.5 Gy-cm2. Conclusions: The addition of mCBCT guidance to SS-RAB allows bronchoscopists to compensate for CTBD, leading to an increase in TIL and diagnostic yield, with acceptable radiation exposure.

With increasing frequency in sublobar resections, accurate intraoperative localization has become essential to ensure adequate resection margins and spare lung parenchyma. Our study evaluates the efficacy of shape-sensing robotic bronchoscopy (SS-RAB) with integrated mobile cone-beam CT (mCBCT) for intraoperative localization of lung tumors using indocyanine green (ICG). We further aimed to explore the feasibility of a single intubation-single positioning technique for bronchoscopy and surgery. We retrospectively reviewed patients who underwent SS-RAB with integrated mCBCT for ICG marking, followed by minimally invasive sublobar resection. ICG marking was deemed successful when it allowed the operative team to localize and resect the lesion with adequate pathology margins. A total of 28 patients with 30 pulmonary lesions from a single institution were included. Median tumor size was 10.5 mm (IQR, 8.7-14.6 mm) and distance from pleura 7.8 mm (IQR, 2.45-13.8 mm). Twenty lesions (66.6%) were solid, 5 lesions (16.6%) semi-solid, and 5 lesions (16.6%) ground-glass. ICG localization was successful in 28 lesions (93%). Nineteen patients (68%) were intubated only with a double-lumen endotracheal tube (DL-ETT), used for bronchoscopy and surgery, and in 10 patients (36%) ICG marking and surgery were both performed in lateral decubitus. One patient developed a small pneumothorax during bronchoscopy which did not prevent ICG injection. SS-RAB with integrated mCBCT for ICG marking is successful and safe. Single intubation with DL-ETT and lateral decubitus positioning for both bronchoscopy and surgery are feasible. Further studies are needed to prove a potential increase in efficiency with this technique.

Atelectasis during bronchoscopy under general anesthesia is very common and can have a detrimental effect on navigational and diagnostic outcomes. While the intraprocedural incidence and anatomic location have been previously described, the severity of atelectasis has not. We reviewed chest CT images of patients who developed atelectasis in the VESPA trial (Ventilatory Strategy to Prevent Atelectasis). By drawing boundaries at the posterior chest wall (A), the anterior aspect of the vertebral body (C), and mid-way between these two lines (B), we delineated at-risk lung zones 1, 2, and 3 (from posterior to anterior). An Atelectasis Severity Score System (“ASSESS”) was created, classifying atelectasis as “mild” (zone 1), “moderate” (zones 1–2), and “severe” (zones 1–2–3). A total of 43 patients who developed atelectasis were included in this study. A total of 32 patients were in the control arm, and 11 were in the VESPA arm; 20 patients (47%) had mild atelectasis, 20 (47%) had moderate atelectasis, and 3 (6%) had severe atelectasis. A higher BMI was associated with increased odds (1.5 per 1 unit change; 95% CI, 1.10–2.04) (p = 0.0098), and VESPA was associated with decreased odds (0.05; 95% CI, 0.01–0.47) (p = 0.0080) of developing moderate to severe atelectasis. ASSESS is a simple method used to categorize intra-bronchoscopy atelectasis, which allows for a qualitative description of this phenomenon to be developed. In the VESPA trial, a higher BMI was not only associated with increased incidence but also increased severity of atelectasis, while VESPA had the opposite effect. Preventive strategies should be strongly considered in patients with risk factors for atelectasis who have lesions located in zones 1 and 2, but not in zone 3.

Diagnostic biomarkers for immune checkpoint inhibitor pneumonitis (ICIP) are lacking. Bronchoalveolar lavage (BAL) lymphocytosis has been associated with ICIP, but studies have not evaluated BAL lymphocytosis as a diagnostic biomarker for ICIP. This study aimed to measure the association of BAL immune cell percentage with ICIP and test its performance as a diagnostic biomarker. We performed a retrospective chart review of 476 patients treated with ICIs for solid organ or hematologic malignancies who underwent BAL between 2016 and 2022. Two independent reviewers, blinded to the results of BAL cell percentage, confirmed the diagnosis of ICIP or other conditions (e.g., pneumonia) based on clinical history and radiology. We constructed logistic regression models to assess the relationship between BAL lymphocyte, eosinophil, and neutrophil percentages and the diagnosis of pneumonitis, and the area under the receiver-operator curves (AUROC) was used to assess their discriminatory function. We measured the association of BAL immune cell percentages with 1-year overall survival using Cox proportional hazard models adjusted for age and cancer diagnosis. Each 1% increase in lymphocyte (OR 1.01, 95% CI 1.01-1.02,  < 0.001) and eosinophil percentage (OR 1.05, 95% CI 1.01-1.11,  = 0.01) were independently associated with pneumonitis, while neutrophil percentage was inversely associated (OR 0.99, 95% CI 0.98-0.99, p = 0.01) with pneumonitis. In multivariable analysis, lymphocyte percentage (OR 1.02, 95% CI 1.009-1.04,  = 0.002) and eosinophil percentage (OR 1.10, 95% CI 1.01-1.23,  = 0.05) were both associated with ICIP. The AUROC for BAL lymphocytes to diagnose ICIP was 0.62 (95% CI 0.57-0.67, optimal cutoff 15.5%, sensitivity 69%, and specificity 52%) and the AUROC for eosinophils was 0.61 (95% CI 0.56-0.66, optimal cutoff 1%, sensitivity 58%, and specificity 62%). In patients with pneumonitis, lymphocyte percentage (HR 0.99, 95% CI 0.97-1.00,  = 0.02), neutrophil percentage (HR 1.01, 95% CI 1.00-1.02,  = 0.05), and eosinophil percentage (HR 0.93, 95% CI 0.86-0.99,  = 0.03) were associated with 1-year survival. BAL lymphocytosis and eosinophilia are associated with ICIP, but their ability to discriminate ICIP from other conditions is modest. BAL immune cell percentages may have prognostic value for 1-year survival, but this likely reflects the morbidity of other pulmonary diseases that require BAL for evaluation.

Background/Objectives: Patients with non-small cell lung cancer (NSCLC) being evaluated for stereotactic body radiation therapy (SBRT) are frequently staged non-invasively with positron emission tomography/computed tomography (PET/CT). Performing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in addition to PET/CT scanning may increase clinical certainty in lymph node staging, but the magnitude of added benefit of EBUS-TBNA over non-invasive staging methods is unclear. Methods: A single-center prospective cohort study involving patients with suspected or confirmed Stage I or IIa NSCLC referred for EBUS-TBNA prior to SBRT was performed. The primary outcome was concordance between PET/CT and EBUS-TBNA for nodal metastases. Secondary endpoints included sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of PET/CT, and clinical outcomes based on staging results. Results: Among 115 patients, the concordance between PET/CT and EBUS-TBNA was 84.3% (95% CI: 0.76 0.90). EBUS-TBNA led to a stage shift in 15.7% of cases: 4 of 98 PET/CT N0 patients (4.1%) had nodal metastases, while 14 of 17 PET/CT N1 patients (82.4%) were downstaged to N0. PET/CT sensitivity was 42.9% (95% CI: 0.09–0.81), specificity 87% (95% CI: 0.79–0.93), PPV 17.6% (95% CI: 0.04–0.43), and NPV 95.9% (95% CI: 0.90–0.99). PET/CT-positive, EBUS-TBNA-negative patients had worse survival (HR 4.25, 95% CI: 1.24–14.53, p = 0.021) compared with double-negative patients. Conclusions: EBUS-TBNA improves staging accuracy over PET/CT in early-stage NSCLC, impacting SBRT candidacy. However, PET/CT-positive, EBUS-TBNA-negative patients had worse outcomes in comparison to double-negative patients, suggesting a need for additional therapy or surveillance in that population.

[This corrects the article DOI: 10.3389/fmed.2025.1582714.].