Lung cancer diagnosis and staging with endobronchial ultrasound-guided transbronchial needle aspiration compared with conventional approaches: an open-label, pragmatic, randomised controlled trial

Abstract

SummaryBackgroundThe diagnosis and staging of lung cancer is an important process that identifies treatment options and guides disease prognosis. We aimed to assess endobronchial ultrasound-guided transbronchial needle aspiration as an initial investigation technique for patients with suspected lung cancer.MethodsIn this open-label, multicentre, pragmatic, randomised controlled trial, we recruited patients who had undergone a CT scan and had suspected stage I to IIIA lung cancer, from six UK centres and randomly assigned them to either endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) or conventional diagnosis and staging (CDS), for further investigation and staging. If a target node could not be accessed by EBUS-TBNA, then endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) was allowed as an alternative procedure. Randomisation was stratified according to the presence of mediastinal lymph nodes measuring 1 cm or more in the short axis and by recruiting centre. We used a telephone randomisation method with permuted blocks of four generated by a computer. Because of the nature of the intervention, masking of participants and consenting investigators was not possible. The primary endpoint was the time-to-treatment decision after completion of the diagnostic and staging investigations and analysis was by intention-to-diagnose. This trial is registered with ClinicalTrials.gov, number NCT00652769.FindingsBetween June 10, 2008, and July 4, 2011, we randomly allocated 133 patients to treatment: 66 to EBUS-TBNA and 67 to CDS (one later withdrew consent). Two patients from the EBUS-TBNA group underwent EUS-FNA. The median time to treatment decision was shorter with EBUS-TBNA (14 days; 95% CI 14–15) than with CDS (29 days; 23–35) resulting in a hazard ratio of 1·98, (1·39–2·82, p<0·0001). One patient in each group had a pneumothorax from a CT-guided biopsy sample; the patient from the CDS group needed intercostal drainage and was admitted to hospital.InterpretationTransbronchial needle aspiration guided by endobronchial ultrasound should be considered as the initial investigation for patients with suspected lung cancer, because it reduces the time to treatment decision compared with conventional diagnosis and staging techniques.FundingUK Medical Research Council.

Ultrasonografía bronquial con aspiración por aguja fina en el estudio lesiones adyacentes a la vía aérea central

“…El rendimiento diagnóstico de esta técnica para el estudio de estructuras cercanas a la vía aérea central o mediastino es alto, en un estudio clínico aleatorizado se comparó el rendimiento de este procedimiento como primera alternativa de eBus-tBnA para lesiones pulmonares centrales -s. Fernández-Bussy et al estudio contra las técnicas quirúrgicas habituales, como resultado se obtuvo que la estrategia de estudio inicial mediante EBUS disminuye en dos semanas el tiempo entre el estudio y la toma de decisión clínica comparada con el protocolo de estudio con imágenes y posterior cirugía, por otro lado, se obtuvo una menor incidencia de toracotomías innecesarias, sin encontrar impacto en la mortalidad, en este estudio EBUS-TBNA presento una sensibilidad de 92% y especificidad de 100% 10 .…”

Utilidad del ultrasonido endobronquial para el diagnóstico y etapificación del cáncer pulmonar

“…Por otro lado, se obtuvo una menor incidencia de toracotomías innecesarias, sin encontrar impacto en la mortalidad. En este estudio EBUS-TBNA presentó una sensibilidad de 92% y especificidad de 100% 17 . En otro estudio de costo efectividad, basado en un estudio clínico aleatorizado publicado en el año 2010, concluyen que el uso de EBUS como estrategia de etapificacion mediastínica inicial, seguido pormediastinoscopia en los casos de presentar EBUS-TBNA negativo, tiene una sensibilidad de 94% para detectar compromiso metastásico N2/ N3 (IC 85-98%), comparado conla estrategia de mediastinoscopia como primera opción que reporta 79% (IC 66-88%).…”

Current advances of endobronchial ultrasonography in the diagnosis and staging of lung cancer

“…If possible, lymph node stations 4R, 4L and 7 should be evaluated in all patients who receive EBUS CP study (42). Because EBUS TBNA is the first choice for LN staging with high sensitivity and specificity, several studies suggest EBUS TBNA for lung cancer diagnosis and staging at the same time because it reduces the time to treatment decision compared with conventional diagnosis and staging techniques (62,63). The Complication rate for EBUS TBNA is low.…”