Background: Different anesthetic protocols may influence endobronchial ultrasound-guided needle aspiration (EBUS-TBNA) outcomes, patient comfort, and even safety. In this study, two anesthesia techniques were assessed and compared for EBUS-TBNA. Methods: A prospective, multicenter study was carried out. Patients were allocated to Group 1 (general anesthesia with neuromuscular blockade and controlled ventilation) and Group 2 (intravenous sedation). EBUS-TBNA accuracy was the primary outcome. Safety, patient comfort and satisfaction, and operators’ difficulties were defined as secondary outcomes. Results: Of the 115 patients enrolled (Group 1 = 59, Group 2 = 56), EBUS-TBNA was performed for hilar or mediastinal lesion diagnosis and lung cancer staging in, respectively, 77 (67%) and 38 (33%) patients. The numbers of lymph nodes stations (1.8 ± 1.0 vs. 1.7 ± 1.0, p = 0.472) and punctures per station (6.9 ± 3.1 vs. 6.0 ± 2.5, p = 0.084) were similar between groups. Adequate samples were obtained from 109 patients (97.3%) with similar diagnostic accuracy. Procedure duration was not significantly different (p = 0.348). Hemodynamic parameters and systolic and diastolic blood pressures were higher in Group 1 at the beginning and at the end of the procedure. Adverse events were equally distributed, and no significant differences were found regarding patient satisfaction and bronchoscopist/anesthesiologist difficulties. Conclusions: The type of anesthesia used did not influence EBUS-TBNA outcomes. EBUS-TBNA performed under sedation or general anesthesia did not affect the diagnostic yield, complication rate, and patients’ comfort and satisfaction.
Identification of targetable molecular changes is essential for selecting appropriate treatment in patients with advanced lung adenocarcinoma. Methods: In this study, a Sanger sequencing plus Fluorescence In Situ Hybridization (FISH) sequential approach was compared with a Next-Generation Sequencing (NGS)-based approach for the detection of actionable genomic mutations in an experimental cohort (EC) of 117 patients with advanced lung adenocarcinoma. Its applicability was assessed in small biopsies and cytology specimens previously tested for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutational status, comparing the molecular changes identified and the impact on clinical outcomes. Subsequently, an NGS-based approach was applied and tested in an implementation cohort (IC) in clinical practice. Using Sanger and FISH, patients were classified as EGFR-mutated (n = 22, 18.8%), ALK-mutated (n = 9, 7.7%), and unclassifiable (UC) (n = 86, 73.5%). Retesting the EC with NGS led to the identification of at least one gene variant in 56 (47.9%) patients, totaling 68 variants among all samples. Still, in the EC, combining NGS plus FISH for ALK, patients were classified as 23 (19.7%) EGFR; 20 (17.1%) KRAS; five (4.3%) B-Raf proto-oncogene (BRAF); one (0.9%) Erb-B2 Receptor Tyrosine Kinase 2 (ERBB2); one (0.9%) STK11; one (0.9%) TP53, and nine (7.7%) ALK mutated. Only 57 (48.7%) remained genomically UC, reducing the UC rate by 24.8%. Fourteen (12.0%) patients presented synchronous alterations. Concordance between NGS and Sanger for EGFR status was very high (κ = 0.972; 99.1%). In the IC, a combined DNA and RNA NGS panel was used in 123 patients. Genomic variants were found in 79 (64.2%). In addition, eight (6.3%) EML4-ALK, four (3.1%), KIF5B-RET, four (3.1%) CD74-ROS1, one (0.8%) TPM3-NTRK translocations and three (2.4%) exon 14 skipping MET Proto-Oncogene (MET) mutations were detected, and 36% were treatable alterations. Conclusions: This study supports the use of NGS as the first-line test for genomic profiling of patients with advanced lung adenocarcinoma.
ResumoIntrodução: Os agentes sedativos têm vindo a ser cada vez mais utilizados na broncofibroscopia (BF) para melhorar o conforto do doente. Devido à sua rápida ação, propriedades ansiolíticas e amnésicas, o midazolam é um dos sedativos mais frequentemente usados. Objetivos: Avaliar o efeito da sedação com midazolam na BF, incluindo a tolerância do doente, complicações e a sua potencial aplicação na prática clínica diária. Material e métodos: Estudo multicêntrico, prospetivo, randomizado, controlado com placebo, com inclusão de 100 indivíduos submetidos a BF em 2 Serviços de Pneumologia. Doentes do Grupo 1 receberam midazolam (0,05 mg/kg) e doentes do Grupo 2 receberam placebo (0,9% NaCl), 5 minutos antes do procedimento. A escala de ansiedade «The Hospital Anxiety and Depression Scale» (HADS-A) foi aplicada para determinar o nível de ansiedade basal do doente. Questionários subjetivos acerca dos principais receios e queixas relativamente à BF foram aplicados antes e depois do exame. Resultados: Média de idades de 56,0 ± 14,1 anos; 66% do sexo masculino. A maioria (65%) dos doentes apresentava baixa pontuação (< 7) na escala HADS-A, sem diferença entre grupos. Não se observaram diferenças significativas entre os 2 grupos no que diz respeito à duração da BF, procedimentos realizados, dose total de lidocaína usada e complicações observadas. A pressão arterial sistólica foi significativamente mais elevada (p < 0,003), durante e após a BF, nos indivíduos do Grupo 2. Os doentes do Grupo 1 apresentaram menos tosse (32 vs 56%; p = 0,03) e dispneia (2% vs 34%; p < 0,001) comparativamente com o Grupo 2, não se registando diferenças significativas relativamente à náusea (6 vs 18%; p > 0,05) e à dor (4 vs 12%; p > 0,05). Foi demonstrada recetibilidade em repetir o exame por todos os doentes do Grupo 1 e em 82% dos doentes do Grupo 2 (p = 0,003).
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