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.

Observational cross-sectional study of 5279 bronchoscopy results for the practical effectiveness of various biopsy techniques in the diagnosis of lung diseases with particular emphasis on lung cancer.

INTRODUCTION: Bronchoscopy is the main method in the diagnosis of various lung diseases. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the most modern bronchoscopic technique useful in diagnosis and staging of lung cancer (LC). OBJECTIVE: The aim of the study was to assess the yield of bronchoscopy in patients with suspected various respiratory diseases including LC. In particular, we examined the efficiency of different biopsy techniques in the diagnosis of LC in correlation with its localisation and pathomorphological type. PATIENTS AND METHODS: The results of pathomorphological examinations from 5279 bronchoscopies performed in 2016-2018 were analysed. The material was collected with EBUS-TBNA, endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and endobronchial forceps biopsy. Clinical and demographic factors were analysed using the Fisher χ2 test. RESULTS: 5279 patients were diagnosed due to various respiratory symptoms. LC was confirmed in 36.42% of patients. 40.81% of patients had no definitive pathomorphological diagnosis. Among patients with LC, the most frequent diagnosis was non-small cell LC: squamous cell lung cancer (SCC)-32.07% and adenocarcinoma (AC)-30.61%, then small cell LC-25.83% and not otherwise specified non-small cell lung cancer (NSCLC-NOS)-11.49%. Diagnosis of SCC was obtained significantly more often (χ2=43.143, p<0.000001) by forceps biopsy (41.09%) than by EBUS-TBNA/EUS-FNA (26.62%). On the contrary, diagnosis of AC or NSCLC-NOS was significantly more often (χ2=20.394, p<0.000007, and χ2=3.902, p<0.05, respectively) observed in EBUS-TBNA/EUS-FNA (34.31% and 12.6%) than in endobronchial biopsies (24.52% and 9.64%). CONCLUSIONS: The use of bronchoscopy in the diagnosis of various lung diseases is vital but also has many limitations. Effectiveness of EBUS-TBNA and endobronchial forceps biopsy in the diagnosis of lung cancer is strongly affected by tumour localisation and type of cancer.

Endobronchial ultrasound in diagnosing and staging of lung cancer by Acquire 22G TBNB versus regular 22G TBNA needles: study protocol of a randomised clinical trial.

INTRODUCTION: Accurate diagnosis and staging of lung cancer is crucial because it directs treatment and prognosis. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound with bronchoscope fine-needle aspiration (EUS-B-FNA) are important in this process by sampling hilar/mediastinal lymph nodes and centrally located lung tumours. With the upcoming of immunotherapy and targeted therapies, assessment of programmed death ligand 1 (PD-L1) expression and molecular profiling has become important but is often impossible in cytological samples obtained through standard 22G TBNA needles. Recently, a three-pronged cutting edge 22G needle was developed that allows for transbronchial needle biopsy (TBNB). Our objective is to determine if EBUS/EUS-B-guided nodal/lung tumour sampling with Acquire 22G TBNB needles results in an improved suitability rate for the assessment of PD-L1 expression in comparison to standard 22G TBNA needles in patients with a final diagnosis of lung cancer. METHODS AND ANALYSIS: This is an investigator-initiated, parallel group randomised clinical trial. Patients are recruited at respiratory medicine outpatient clinics of participating university and general hospitals in the Netherlands, Poland and Italy. In total 158 adult patients with (suspected) lung cancer are included if they have an indication for mediastinal/hilar lymph node or lung tumour sampling by EBUS-TBNA and/or EUS-B-FNA based on current clinical guidelines. Web-based randomisation between the two needles will be performed. Samples obtained from mediastinal/hilar lymph nodes and/or primary tumour will be processed for cytology smears and cell block analysis and reviewed by blinded reference pathologists. An intention-to-treat analysis will be applied. Patients with missing data will be excluded from analysis for that specific variable but included in the analysis of other variables. This study is financially supported by Boston Scientific. ETHICS AND DISSEMINATION: The study was approved by the local Ethics Committee (Medisch Ethische Toetsingscommissie Amsterdam Medical Center (AMC)). Dissemination will involve publication in a peer-reviewed biomedical journal. TRIAL REGISTRATION NUMBER: NL7701; Pre-results.

Influence of bilateral mediastinal lymph node dissection on survival in non-small cell lung cancer patients - Randomized study.

OBJECTIVES: This study aimed to analyze the effect of bilateral mediastinal lymphadenectomy (BML) on survival of non-small cell lung cancer (NSCLC) patients. The hypothesis was: BML offers survival benefit as compared with SLND. METHODS: A randomized clinical trial including stage I-IIIA NSCLC patients was performed. All patients underwent anatomical lung resection. BML was performed during the same operation via additional cervical incision (BML group). In the control group, standard lymphadenectomy (systematic lymph node dissection, SLND) was performed. RESULTS: In total, 102 patients were randomized. No significant difference was found in the type of lung resection, blood loss, chest tube output, air leak, pain, and complications (p = 0.188-0.959). In the BML group, the operative time was longer (318 vs 223 min, p < 0.001) with higher number of removed N2 nodes (24 vs 14, p < 0.001). The 5-year survival rate was 72 % in the BML group vs 53 % in the SLND group (OR 2.33, 95 % CI 0.95-5.69, p = 0.062). Separate comparisons for different lobar locations of the tumor have shown no significant difference in survival for the right lung tumors and left upper lobe tumors. For the left lower lobe tumors, survival time was longer in the BML group (p = 0.021), and the 5-year survival rate was 90.9 % vs 37.5 %, (OR 16.66, 95 % CI 1.36-204.04, p = 0.0277). CONCLUSIONS: In patients with NSCLC located in the left lower lobe, bilateral lymph node dissection may be associated with better survival. The invasiveness of BML is comparable to that of SLND.

Endobronchial ultrasound for T4 staging in patients with resectable NSCLC.

BACKGROUND: In lung cancer patients, accurate assessment of mediastinal and vascular tumor invasion (stage T4) is crucial for optimal treatment allocation and to prevent unnecessary thoracotomies. We assessed the diagnostic accuracy of linear endobronchial ultrasound (EBUS) for T4-status in patients with centrally located lung cancer. METHODS: This is a retrospective study among consecutive patients who underwent EBUS for diagnosis and staging of lung cancer in four hospitals in The Netherlands (Amsterdam, Leiden), Italy (Bologna) and Poland (Zakopane) between 04-2012 and 04-2019. Patients were included if the primary tumor was detected by EBUS and subsequent surgical-pathological staging was performed, which served as the reference standard. T4-status was extracted from EBUS and pathology reports. Chest CT's were re-reviewed for T4-status. RESULTS: 104 patients with lung cancer in whom EBUS detected the primary tumour, and who underwent subsequent surgical-pathological staging were included. 36 patients (35 %) had T4-status, based on vascular (n = 17), mediastinal (n = 15), both vascular and mediastinal (n = 3), or oesophageal invasion (n = 1). For EBUS, sensitivity, specificity, PPV and NPV for T4-status were (n = 104): 63.9 % (95 %CI 46.2-79.2 %), 92.6 % (83.7-97.6 %), 82.1 % (65.6-91.7 %), and 82.9 % (75.7-88.2 %), respectively. For chest CT (n = 72): 61.5 % (95 %CI 40.6-79.8 %), 37.0 % (23.2-52.5 %), 35.6 % (27.5-44.6 %), and 63.0 % (47.9-75.9 %), respectively. When combining CT and EBUS with concordant T4 status (n = 33): 90.9 % (95 %CI 58.7-99.8 %), 77.3 % (54.6-92.20 %), 66.7 % (47.5-81.6 %), and 94.4 % (721-99.1%), respectively. CONCLUSION: Both EBUS and CT alone are inaccurate for assessing T4-status as standalone test. However, combining a negative EBUS with a negative CT may rule out T4-status with high certainty.

Usefulness of combined endobronchial and endoscopic ultrasound-guided needle aspiration in the diagnosis of sarcoidosis: a prospective multicenter trial.

INTRODUCTION: Needle biopsy of enlarged lymph nodes is an accepted method for the diagnostic workup of sarcoidosis, but the optimal endosonography­guided approach is yet to be determined. OBJECTIVES: The aim of our study was to assess the relative diagnostic yield of combined ultrasound­guided needle aspiration (CUS­b­NA), which includes endobronchial ultrasound­guided transbronchial needle aspiration (EBUS­TBNA) with endoscopic ultrasound fine­needle aspiration (EUS­b­FNA), as well as the role of the cell block (CB) technique and lymph node localization in the diagnostic workup of sarcoidosis. PATIENTS AND METHODS: This was a prospective multicenter study including consecutive patients with clinical suspicion of stage I or II sarcoidosis. CUS­b­NA with smears and CB technique were performed in the whole study group. If a biopsy result was not conclusive, an invasive diagnostic workup and a 6-month follow­up were scheduled. RESULTS: Out of 77 screened patients, 54 signed written consent and 50 were enrolled for the final analysis. The overall sensitivity of EBUS­TBNA, EUS­b­FNA, and CUS­b­NA was 76.6%, 70.2%, and 91.7%, respectively. There were no differences between EBUS­TBNA and EUS­b­FNA (P = 0.52) but CUS­b­NA had a higher diagnostic yield (P = 0.005 and P = 0.001, respectively). Adding the CB method to smear technique (P = 0.008) and biopsy of the subcarinal lymph nodes increased the diagnostic yield (P = 0.001).  Conclusions: The diagnostic yield of CUS­b­NA is higher than that of endosonographic techniques alone in the diagnostic workup of stage I and II sarcoidosis. The preparation of cytological material including CB and the choice of the subcarinal lymph node station for the biopsy increase the diagnostic efficacy.

Transbronchial lung cryobiopsy guided by radial mini-probe endobronchial ultrasound in interstitial lung diseases - a multicenter prospective study.

INTRODUCTION: Transbronchial lung cryobiopsy (TBLC) is commonly used in diagnosing interstitial lung diseases (ILDs). Ageneral anesthesia with endotracheal intubation, balloon blockers and fluoroscopy control is the most common modality. Simplifying the procedure without decreasing it's safety could result in wider use. Prospective, observational study was conducted in three Polish pulmonology centers to evaluate safety and diagnostic yield of TBLC under conscious sedation, without intubation and bronchial blockers and with radial-EBUS guidance instead of fluoroscopy. MATERIAL AND METHODS: In patients suspected of ILD, in accordance with high resolution computer tomography (HRCT) selected lung segments were examined with radial-EBUS mini probe without aguide sheath. If the lung infiltrations were visible this locations were preferred. If not, specimens were taken from two different segments of the same lobe. Two to five biopsies with freezing time 5-8 seconds were performed. Moreover ultrasound examination was used to avoid injury of lung vessels. RESULTS: From March 2017 to September 2019 - 114 patients (M: 59, F: 55) of mean (SD) age 54 (14) years were included to the study on the basis of medical history and HRCT. Histopathology was conclusive in 90 (79%) patients and included 16 different diagnoses (sarcoidosis, EAA, COP predominantly). 24 inconclusive biopsies of unclassifiable pulmonary fibrosis were followed up. Complications included five cases (4.4%) of pneumothorax requiring achest tube drainage and aminor and moderate bleeding in few cases. There was no need for use of balloon bronchial blockers. CONCLUSIONS: TBLC under conscious sedation guided by radial EBUS mini-probe is novel, reasonable and safe technique for histological diagnosis of ILDs.

[Endoscopic ultrasound-guided needle aspiration in lung cancer]. / Przezprzelykowa biopsja wezlów chlonnych sródpiersia pod kontrola ultrasonografii wewnatrzprzelykowej w czasie rzeczywistym w diagnostyce raka pluca.

INTRODUCTION: The aim of the study was to assess the diagnostic yield of transoesophageal endoscopic ultrasound-guided needle aspiration (EUS-NA) in lung cancer (LC). MATERIAL AND METHODS: Real time EUS-NA was performed under local anaesthesia and sedation in consecutive LC patients. All negative EUS-NA results in NSCLC patients were verified by transcervical extended bilateral mediastinal lymphadenectomy (TEMLA). RESULTS: In 146 patients there were 206 biopsies performed in lymph node stations: subcarinal (7):124, left lower paratracheal (4L):70, paraoesophageal (8):9 and pulmonary ligament (9):3. A mean short axis of punctured node was 10+/-6.3 (95% CI) mm. Lymph node biopsy was technically successful in 95.6% and was diagnostic in 40.1% of LC patients. In NSCLC staging, the sensitivity of EUS-NA calculated on the per-patient basis was 85.5%, specificity 100%, accuracy 93.6% and negative predictive value (NPV) 89.7% in stations accessible for EUS-NA, but in all mediastinal stations it was 70.7%, 100%, 84.3% and 74.7, respectively (p=0.009). The sensitivity of EUS-NA in NSCLC staging patients, calculated on the per-biopsy basis was 88.6%, specificity 100%, accuracy 95.4% and NPV 91.4%. A diagnostic yield of EUS-NA on the per-biopsy basis was higher for station 4L than 7, but the difference was not significant (chi2 p=0.4). CONCLUSIONS: The diagnostic value of EUS-NA in LC is high. In NSCLC staging EUS-NA is insufficient and should be complemented by other invasive techniques, especially those that give access to the right paratracheal region.

[Ultrasound guided transbronchial needle aspiration as a diagnostic tool for lung cancer and sarcoidosis]. / Przezoskrzelowa biopsja wezlów chlonnych sródpiersia i wnek pluca pod kontrola ultrasonografii wewnatrzoskrzelowej w czasie rzeczywistym w diagnostyce raka pluca i sarkoidozy.

INTRODUCTION: The aim of the study was to assess the diagnostic yield of ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in mediastinal or hilar adenopathy in: 1) staging of non-small cell lung cancer (NSCLC) (97); 2) other malignant neoplasms including: small cell lung cancer (SCLC), metastatic neoplasms and Hodgkin's disease (16); 3) NSCLC recurrence (7); 4) sarcoidosis and other non-malignant diseases (29). MATERIAL AND METHODS: Real time EBUS-TBNA was performed under local anaesthesia and sedation in 149 consecutive patients - 237 biopsies in groups of lymph nodes: subcarinal (7) - 107, all paratracheal (2R, 2L, 4R, 4L) - 86, hilar (10R, 10L) - 41 and interlobar (11R, 11L) - 3. A mean axis of punctured node was 15 mm (range: 7-42 mm). All negative results were verified by transcervical extended bilateral mediastinal lymphadenectomy (TEMLA), mediastinoscopy or thoracotomy. RESULTS: Lymph node biopsy was technically successful in 92% and was diagnostic in 55% of lung cancer patients and in 85.7% of sarcoidosis patients. In NSCLC staging sensitivity of EBUS-TBNA was 88.7%, specificity 100%, accuracy 92.8% and NPV 83.3% (89.7%, 100%, 94.9% and 90.9% per biopsy), and in the whole group it was 91.5%, 98.7%, 94.6% and 87.3% respectively. In 7.2% of NSCLC staging patients with false negative results of EBUS-TBNA (mainly subcarinal) there was observed partial involvement of metastatic lymph nodes, mean 34.3% (range 10-50%), confirmed by TEMLA. CONCLUSION: The diagnostic value of EBUS-TBNA is very high in lung cancer, NSCLC staging and sarcoidosis.

Effect of bilateral mediastinal lymphadenectomy on short-term pulmonary function.

OBJECTIVE: To assess if the bilateral mediastinal lymphadenectomy results in lymphatic congestion in the lungs producing clinically significant impairment of respiratory function. METHODS: In the prospective, randomized, double-blind clinical study, non-small cell lung carcinoma patients underwent preoperatively mediastinoscopy or the transcervical extended mediastinal lymphadenectomy (TEMLA). In both groups, the blood gas analysis and spirometry were measured preoperatively and on the 1st, 3rd, and 5th postoperative day, and the carbon monoxide diffusing capacity of the lung (DLCO) and lung compliance were measured preoperatively and on the 3-5 postoperative day. Any respiratory complications were also recorded. RESULTS: Forty-one patients were randomized: 21 to the TEMLA group and 20 to the mediastinoscopy group. There was no significant difference of the baseline and the 1st, 3rd, and 5th day measurements of vital capacity and forced expiratory volume (FEV1) (p>0.98), pH, pO(2), pCO(2), standard bicarbonates and base excess (p>0.31), nor significant difference of baseline and 3-5 day measurements for DLCO (p=0.91) and lung compliance (p=0.38). The incidence of respiratory insufficiency was not significantly different (p=0.51). CONCLUSIONS: (1) Complete excision of mediastinal lymph nodes stations 1, 2R, 2L, 3A, 4R, 4L, 5, 6, 7, and 8 (TEMLA) is not associated with greater incidence of respiratory insufficiency comparing with standard mediastinoscopy. (2) The TEMLA procedure does not produce greater alterations in spirometry, blood gas analysis, DLCO and lung compliance comparing with standard mediastinoscopy.

The transcervical extended mediastinal lymphadenectomy versus cervical mediastinoscopy in non-small cell lung cancer staging.

OBJECTIVE: To compare the diagnostic yield of the transcervical extended mediastinal lymphadenectomy (TEMLA) and the cervical mediastinoscopy (CM) in detecting metastatic mediastinal lymph nodes in NSCLC patients. METHODS: Prospective, randomized, single-blind clinical study. RESULTS: There were 41 NSCLC patients enrolled in the study; 21 were randomized to the TEMLA group and 20 to the cervical mediastinoscopy group. The TEMLA revealed mediastinal metastases in 7 patients, and mediastinoscopy in 3. In the TEMLA group one patient out of the 14 with negative nodes was finally found unfit for surgery, and in the remaining 13 lung resections with mediastinal dissection were performed. In the mediastinoscopy group one patient out of the 17 with negative nodes was finally found unfit for surgery and another one refused surgery, so in 15 of them lung resections with mediastinal dissection were performed. In no patient in the TEMLA group did the pathological examination of the operative specimen reveal metastatic lymph nodes, whereas in the mediastinoscopy group metastatic nodes were found in 5 patients. The number of false negative results was significantly greater in the mediastinoscopy group (5 vs 0, p=0.019), and the difference was the reason for terminating the randomization before reaching the initially planned number of 100 patients. The sensitivity of mediastinoscopy was 37.5% and its negative predictive value was 66.7%, compared to 100% and 100% in the TEMLA group. The comparison of the time of the operation, blood loss, complications, postoperative pain and the use of analgetics has shown significant differences between groups only regarding the operative time and the pain intensity, being greater in the TEMLA group. CONCLUSIONS: 1. The sensitivity and the NPV of the TEMLA in detecting mediastinal metastases in NSCLC are significantly greater than those of cervical mediastinoscopy. 2. The invasiveness of TEMLA and mediastinoscopy does not significantly differ, except for the postoperative pain.