EBUS versus EUS-B for diagnosing sarcoidosis: The International Sarcoidosis Assessment (ISA) randomized clinical trial.

BACKGROUND AND OBJECTIVE: Endosonography with intrathoracic nodal sampling is proposed as the single test with the highest granuloma detection rate in suspected sarcoidosis stage I/II. However, most studies have been performed in limited geographical regions. Studies suggest that oesophageal endosonographic nodal sampling has higher diagnostic yield than endobronchial endosonographic nodal sampling, but a head-to-head comparison of both routes has never been performed. METHODS: Global (14 hospitals, nine countries, four continents) randomized clinical trial was conducted in consecutive patients with suspected sarcoidosis stage I/II presenting between May 2015 and August 2017. Using an endobronchial ultrasound (EBUS) scope, patients were randomized to EBUS or endoscopic ultrasound (EUS)-B-guided nodal sampling, and to 22- or 25-G ProCore needle aspiration (2 × 2 factorial design). Granuloma detection rate was the primary study endpoint. Final diagnosis was based on cytology/pathology outcomes and clinical/radiological follow-up at 6 months. RESULTS: A total of 358 patients were randomized: 185 patients to EBUS-transbronchial needle aspiration (EBUS-TBNA) and 173 to EUS-B-fine-needle aspiration (FNA). Final diagnosis was sarcoidosis in 306 patients (86%). Granuloma detection rate was 70% (130/185; 95% CI, 63-76) for EBUS-TBNA and 68% (118/173; 95% CI, 61-75) for EUS-B-FNA (p = 0.67). Sensitivity for diagnosing sarcoidosis was 78% (129/165; 95% CI, 71-84) for EBUS-TBNA and 82% (115/141; 95% CI, 74-87) for EUS-B-FNA (p = 0.46). There was no significant difference between the two needle types in granuloma detection rate or sensitivity. CONCLUSION: Granuloma detection rate of mediastinal/hilar nodes by endosonography in patients with suspected sarcoidosis stage I/II is high and similar for EBUS and EUS-B. These findings imply that both diagnostic tests can be safely and universally used in suspected sarcoidosis patients.

Current Practice of Airway Stenting in the Adult Population in Europe: A Survey of the European Association of Bronchology and Interventional Pulmonology (EABIP).

BACKGROUND: Airway stenting (AS) commenced in Europe circa 1987 with the first placement of a dedicated silicone airway stent. Subsequently, over the last 3 decades, AS was spread throughout Europe, using different insertion techniques and different types of stents. OBJECTIVES: This study is an international survey conducted by the European Association of Bronchology and Interventional Pulmonology (EABIP) focusing on AS practice within 26 European countries. METHODS: A questionnaire was sent to all EABIP National Delegates in February 2015. National delegates were responsible for obtaining precise and objective data regarding the current AS practice in their country. The deadline for data collection was February 2016. RESULTS: France, Germany, and the UK are the 3 leading countries in terms of number of centres performing AS. These 3 nations represent the highest ranked nations within Europe in terms of gross national income. Overall, pulmonologists perform AS exclusively in 5 countries and predominately in 12. AS is performed almost exclusively in public hospitals. AS performed under general anaesthesia is the rule for the majority of institutions, and local anaesthesia is an alternative in 9 countries. Rigid bronchoscopy techniques are predominant in 20 countries. Amongst commercially available stents, both Dumon and Ultraflex are by far the most commonly deployed. Finally, 11 countries reported that AS is an economically viable activity, while 10 claimed that it is not. CONCLUSION: This EABIP survey demonstrates that there is significant heterogeneity in AS practice within Europe. Therapeutic bronchoscopy training and economic issues/reimbursement for procedures are likely to be the primary reasons explaining these findings.

[Advances in endoscopic diagnosis of sarcoidosis]. / Postepy w endoskopowej diagnostyce sarkoidozy.

A diagnosis of pulmonary sarcoidosis is based on the assessment of clinical outcome, radiology findings and detection of noncaseating granulomas in cytology or histology specimens. Cytological material obtained from enlarged lymph nodes and/or histological specimens from bronchial mucosa and lung tissue are examined according to sarcoidosis stage. The most available are standard bronchoscopic methods as conventional transbronchial needle aspiration (cTBNA), endobronchial biopsy (EBB) and transbronchial lung biopsy (TBLB) both performed with use of forceps. The new endoscopic techniques introduced to pulmonary diagnostics are: endobronchial ultrasoundguided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) or if used by the ultrasound bronchoscope (EUS-b-FNA) and transbronchial lung cryobiopsy (TBLC). Considering a dynamic improvement in cytology assessment techniques (processed as cytology smears and cell blocks) the endoscopic methods with use of fine needle aspiration biopsy of enlarged lymph nodes became a method of choice in sarcoidosis with lymphadenopathy, and published data suggest a higher diagnostic yield when performed under endosonographic guidance. The optimal approach (transbronchial or transesophageal) and the selection of mediastinal lymph node stations considered for biopsy still need evaluation. Also TBLC, successfully used in the diagnosis of other diffuse parenchymal lung diseases, requires more experiences and trials to establish its role in diagnosis of pulmonary sarcoidosis.

The influence of lung volume reduction with intrabronchial valves on the quality of life of patients with heterogeneous emphysema - a prospective study.

INTRODUCTION: A heterogeneous emphysema is one of the most severe forms of chronic obstructive pulmonary disease (COPD). In some cases, besides the standard pharmacotherapy, a new treatment option of emphysema can be used - bronchoscopic lung volume reduction (BLVR) with the use of intrabronchial valves. OBJECTIVES: To examine the health-related quality of life (HRQoL) of patients with severe emphysema after intrabronchial valve (IBV) implantation for the treatment of one lung. MATERIAL AND METHODS: From 2011 to 2013 a single centre prospective observational study was performed. The study assessed the effect of the therapeutic BLVR intervention, measured by St. George Respiratory Questionnaire (SGRQ). A statistical analysis by use of Wilcoxon test for dependent variables was performed. RESULTS: Twenty patients were enrolled to the study (mean age 63 ± 10 years), all ex-smokers with tobacco exposure 38 ± 11.3 packyears. After 3 months of IBV treatment the average SGRQ score improved significantly in total (-12.8; p < 0.001) and in domains and the differences were for: "symptoms" (-8.5; p < 0.001), "activity" (-13.9; p < 0.001) and "influence on life"(-13.5; p < 0.002). CONCLUSIONS: The presented study revealed a significant improvement of the quality in the life measured by SGRQ after IBV treatment for heterogeneous emphysema. For the first time our study showed the significant improvement of all three domains of SGRQ after IBV treatment.

Endosonography vs conventional bronchoscopy for the diagnosis of sarcoidosis: the GRANULOMA randomized clinical trial.

IMPORTANCE: Tissue verification of noncaseating granulomas is recommended for the diagnosis of sarcoidosis. Bronchoscopy with transbronchial lung biopsies, the current diagnostic standard, has moderate sensitivity in assessing granulomas. Endosonography with intrathoracic nodal aspiration appears to be a promising diagnostic technique. OBJECTIVE: To evaluate the diagnostic yield of bronchoscopy vs endosonography in the diagnosis of stage I/II sarcoidosis. DESIGN, SETTING, AND PATIENTS: Randomized clinical multicenter trial (14 centers in 6 countries) between March 2009 and November 2011 of 304 consecutive patients with suspected pulmonary sarcoidosis (stage I/II) in whom tissue confirmation of noncaseating granulomas was indicated. INTERVENTIONS: Either bronchoscopy with transbronchial and endobronchial lung biopsies or endosonography (esophageal or endobronchial ultrasonography) with aspiration of intrathoracic lymph nodes. All patients also underwent bronchoalveolar lavage. MAIN OUTCOMES AND MEASURES: The primary outcome was the diagnostic yield for detecting noncaseating granulomas in patients with a final diagnosis of sarcoidosis. The diagnosis was based on final clinical judgment by the treating physician, according to all available information (including findings from initial bronchoscopy or endosonography). Secondary outcomes were the complication rate in both groups and sensitivity and specificity of bronchoalveolar lavage in the diagnosis of sarcoidosis. RESULTS: A total of 149 patients were randomized to bronchoscopy and 155 to endosonography. Significantly more granulomas were detected at endosonography vs bronchoscopy (114 vs 72 patients; 74% vs 48%; P < .001). Diagnostic yield to detect granulomas for endosonography was 80% (95% CI, 73%-86%); for bronchoscopy, 53% (95% CI, 45%-61%) (P < .001). Two serious adverse events occurred in the bronchoscopy group and 1 in the endosonography group; all patients recovered completely. Sensitivity of the bronchoalveolar lavage for sarcoidosis based on CD4/CD8 ratio was 54% (95% CI, 46%-62%) for flow cytometry and 24% (95% CI, 16%-34%) for cytospin analysis. CONCLUSION AND RELEVANCE: Among patients with suspected stage I/II pulmonary sarcoidosis undergoing tissue confirmation, the use of endosonographic nodal aspiration compared with bronchoscopic biopsy resulted in greater diagnostic yield. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00872612.

Endobronchial ultrasound in diagnosing and staging of lung cancer by Acquire 22G TBNB versus regular 22G TBNA needles: A randomized clinical trial.

OBJECTIVES: Endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) has an important role in the diagnosis and staging of lung cancer. Evaluation of programmed death ligand 1 (PD-L1) expression and molecular profiling has become standard of care but cytological samples frequently contain insufficient tumor cells. The 22G Acquire needle with Franseen needle tip was developed to perform transbronchial needle biopsy (TBNB) with improved tissue specimens. This study evaluated if the 22G Acquire TBNB needle results in enhanced PD-L1 suitability rate compared to the regular Expect 22G TBNA needle. METHODS: in this multi-center randomized clinical trial (Netherlands Trial Register NL7701), patients with suspected (N)SCLC and an indication for mediastinal/hilar staging or lung tumor diagnosis were recruited in five university and general hospitals in the Netherlands, Poland, Italy and Czech Republic. Patients were randomized (1:1) between the two needles. Two blinded reference pathologists evaluated the samples. The primary outcome was PD-L1 suitability rate in patients with a final diagnosis of lung cancer. In case no malignancy was diagnosed, the reference standard was surgical verification or 6 month follow-up. RESULTS: 154 patients were randomized (n = 76 Acquire TBNB; n = 78 Expect TBNA) of which 92.9% (n = 143) had a final malignant diagnosis. Suitability for PD-L1 analysis was 80.0% (n = 56/70; 95 %CI 0.68-0.94) with the Acquire needle and 76.7% (n = 56/73; 95 %CI 0.65-0.85) with the Expect needle (p = 0.633). Acquire TBNB needle specimens provided more frequent superior quality (65.3% (95 %CI 0.57-0.73) vs 49.4% (95 %CI 0.41-0.57, p = 0.005) and contained more tissue cores (72.0% (95 %CI 0.60-0.81) vs 41.0% (95 %CI 0.31-0.54, p < 0.01). There were no statistically significant differences in tissue adequacy, suitability for molecular analysis and sensitivity for malignancy and N2/N3 disease. CONCLUSION: The 22G Acquire TBNB needle procured improved quality tissue specimens compared to the Expect TBNA needle but this did not result in an improved the suitability rate for PD-L1 analysis.

Endosonography and endosonography guided needle aspiration for left adrenal gland assessment in lung cancer patients - 10 years' experience.

INTRODUCTION: Lung cancer patients (LCP) require invasive evaluation of left adrenal glands (LAG) if distant metastases (M1b/1c) are suspected in CT or PET-CT. Only few studies showed utility of endosonography and particularly EUS-b-FNA as minimally invasive endoscopic method of LAG analysis. MATERIAL AND METHODS: A retrospective study of consecutive LCP was conducted in two pulmonology centers between January 2010 and December 2019. Records of complete endosonographic staging with use of single ultrasound bronchoscope or two scopes were overviewed. The analysis included cases of enlarged LAG (body size or limbs > 10 mm) examined and sampled by EUS-b-FNA or EUS-FNA. RESULTS: 142 of 2596 LCP staged by complete endosonography (M: 88, F: 54 mean age 64.7) had enlarged LAG, which were biopsied by conventional EUS-FNA (52) and/or by EUS-b-FNA (90). Strong correlation with gland diameter (P < 0.001) was observed. The incidence of LAG metastases in analyzed group was 52.1% (74/142) and regarding histology: SCLC 76.9% (10/13), adenocarcinoma 66.7% (44/66), NSCLC 56.3% (9/16) and SCC 17.5% (7/40). A specificity and PPV for both methods were 100%. A sensitivity, accuracy and NPV for EUS-FNA were 91.7%, 96.2%, 93.3% and for EUS-b-FNA 88%, 93.3% and 87%, respectively and no significant differences for both methods were noted (P = 0.62, 0.44, 0.35). No severe complications afterall biopsies were observed. A six months clinical follow up included all negative LCP with enlarged LAG. CONCLUSIONS: After our study EUS-b-FNA seems to be a reasonable method of choice for LAG assesssment in LCP.

Ultrasound predictors of left adrenal metastasis in patients with lung cancer: a comparison of computed tomography, positron emission tomography-computed tomography, and endoscopic ultrasound using ultrasound bronchoscope.

INTRODUCTION: Patients with resectable lung cancer require invasive evaluation of the enlarged left adrenal gland (LAG). Few studies showed the utility of endoscopic ultrasound using ultrasound bronchoscope (EUS­B) in LAG assessment. Moreover, little is known on the combination of computed tomography (CT), positron emission tomography-computed tomography (PET­CT), and EUS­B for predicting left adrenal metastasis. PATIENTS AND METHODS: In this retrospective cohort study performed from 2012 to 2019, patients with left adrenal enlargement were evaluated by CT, PET­CT, and EUS­B, followed by complete endoscopic mediastinal staging. The adrenal glands were sampled by EUS­B-guided fine­needle aspiration. Patients were followed for 6 months. RESULTS: During the staging of lung cancer in 2176 patients, 113 enlarged LAGs (5.19%) were biopsied. Malignancy was reported in 51 LAGs (45.13%). Endoscopic ultrasound upstaged 7 patients (6.2%) and downstaged 11 patients (9.37%) after false CT or PET­CT findings. There were no biopsy­related complications. Radiologic predictors of left adrenal metastases had the highest yield at the following cutoff points: Hounsfield units >23, standardized uptake value >4.2, and LAG size >25 mm. Hypoechogenic LAGs with loss of sea­gull shape on EUS­B were associated with a 28.67­fold higher likelihood of metastases. The sensitivity, specificity, accuracy, negative predictive value, and positive predictive value for all ultrasound predictors were 86.21%, 85.45%, 85.84%, 85.45%, and 86.21%, respectively. When combined with radiologic features, the respective values were 93.10%, 94.55%, 93.81%, 92.86%, and 94.74%. CONCLUSIONS: Hypoechogenicity and loss of sea­gull shape on EUS­B are the most reliable predictors of left adrenal metastasis. The combination of CT, PET­CT, and EUS­B improves the noninvasive diagnosis of left adrenal metastases in lung cancer patients.

[Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) for staging of non-small-cell lung cancer (NSCLC)]. / TEMLA--rozszerzone wyciecie wezlów chlonnych sródpiersia w diagnostyce niedrobnokomórkowego raka pluca.

INTRODUCTION: The aim of the study is to analyze diagnostic yield of the new surgical technique--the Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) in preoperative staging of Non-Small-Cell Lung Cancer (NSCLC). MATERIAL AND METHODS: Operative technique included 5-8 cm collar incision in the neck, elevation of the sternal manubrium with a special retractor, bilateral visualization of the laryngeal recurrent and vagus nerves and dissection of all mediastinal nodal stations except of the pulmonary ligament nodes (station 9). RESULTS: 698 patients (577 men, 121 women), of mean age 62.8 (41-79) were operated on from 1.1.2004 to 31.1.2010, including 501 squamous-cell carcinomas, 144 adenocarcinomas, 25 large cell carcinomas and 28 others. Mean operative time was 128 min. (45 to 330 min) and 106.5 min. in the last 100 patients. 30-day mortality was 0.7 % (unrelated causes) and morbidity 6.6%. The mean number of dissected nodes during TEMLA was 37.9 (15 to 85). Metastatic N2 and N3 nodes were found in 152/698 (21.8%) and 26/698 patients (3.7%), respectively. Subsequent thoracotomy was performed in 445/513 patients (86.7%) after negative result of TEMLA. During thoracotomy, omitted N2 was found in 7/445 (1.6%) patients. Sensitivity of TEMLA in discovery of metastatic N2-3 nodes was 96.2 %, specificity was 100%, accuracy was 99,0%, Negative Predictive Value (NPV) was 98.7 % and Positive Predictive Value (PPV) was 100%. CONCLUSIONS: TEMLA is a new minimally invasive surgical procedure providing unique possibility to perform very extensive, bilateral mediastinal lymphadenectomy with very high diagnostic yield in staging of NSCLC Pneumonol.

Comparison of the diagnostic effectiveness between an expert and a student in the diagnosis of sarcoidosis by transbronchial biopsy of mediastinal lymph nodes under the control of endosonography.

INTRODUCTION: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lymph nodes is currently considered to be the most effective minimally invasive diagnostic method in patients with suspected stage I and II sarcoidosis. However, diagnostic effectiveness depends on the experience and skills of the doctor which is dependent on the number of correctly performed procedures. The aim of the study is to compare the diagnostic effectiveness of the EBUS-TBNA test obtained by an expert in this field vs that of his student. MATERIAL AND METHODS: in patients with a clinical and radiological suspicion of sarcoidosis, EBUS-TBNA procedures were performed by an expert (over 1000 previously performed tests) and by his student who completed basic training (15 procedures performed). In the expert's opinion, the student was experienced enough to perform the EBUS-TBNA on his own. Previously, more than 100 conventional fibreoptic bronchoscopies had been performed by the student. During that time, he had been working in the department of pulmonary diseases and tuberculosis for two years. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), negative likelihood ratio (LR-), and accuracy of the EBUS-TBNA test in diagnosing sarcoidosis were calculated. Statistical evaluation was made using ROC curves for the expert and for the student. RESULTS: The study included 215 patients between 22-68 years of age with suspected sarcoidosis who were diagnosed between 2013-2016. 124 EBUS-TBNA tests were performed by the expert, and 91 procedures were performed by the student. The presence of sarcoid granulomas was confirmed by a biopsy in 165 (76.7%) patients. In terms of the diagnosis of sarcoidosis, a higher sensitivity and accuracy of the EBUS test was found in the procedures done by the expert (76.7% and 95.3%, respectively) as compared to the results obtained by the student (66.1% and 93.1%, respectively). However, these differences were not statistically significant (p = 0.11). All tests were assessed in a hospital pathology unit, but not necessarily by one person, which may be a limitation of our research. In this study, only cytological smears were taken into consideration. CONCLUSIONS: In the diagnosis of sarcoidosis, the student, after appropriate training by an expert, achieved a comparable level of diagnostic effectiveness with EBUS-TBNA after performing 90 tests independently.