BACKGROUND: Conventional transbronchial needle aspiration (c-TBNA) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are both valuable diagnostic techniques for the diagnosis of hilar/mediastinal lesions. Although a superiority of EBUS-TBNA over c-TBNA may be expected, evidence-based data on a direct comparison between these 2 procedures are still lacking. OBJECTIVES: We aimed to test the superiority of EBUS-TBNA over c-TBNA in a randomized trial and to evaluate the cost-effectiveness profile of a staged strategy, including c-TBNA as initial test followed by EBUS-TBNA, in case of inconclusive results at rapid on-site evaluation. METHODS: Eligible patients were randomized 1:1 to either the EBUS-TBNA or c-TBNA group. The primary endpoint was to test the superiority of EBUS-TBNA sensitivity over c-TBNA. The secondary endpoints included the sensitivity of the staged strategy, as well as costs and safety related to each procedure and to their sequential combination. RESULTS: A total of 253 patients were randomized to either EBUS-TBNA (n = 127) or c-TBNA (n = 126), and 31 patients of the c-TBNA group subsequently underwent EBUS-TBNA. The sensitivity of EBUS-TBNA was higher, but not significantly superior to that of c-TBNA (respectively. 92% [95% CI 87-97] and 82% [95% CI 75-90], p > 0.05). The sensitivity of the staged strategy was 94% (95% CI 89-98). No major adverse events occurred. CONCLUSIONS: EBUS-TBNA was the single best diagnostic tool, although not significantly superior to c-TBNA. Due to the favorable cost-effectiveness profile of their sequential combination, in selected scenarios with a high probability of success from the standard procedure, these should not be necessarily intended as competitive and the staged strategy could be considered in clinical practice.

Conventional versus Ultrasound-Guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymph Adenopathies: A Randomized Controlled Trial / Bonifazi, Martina; Tramacere, I; Zuccatosta, L; Mei, Federico; Sediari, Michele; Paonessa, Mc; Gasparini, Stefano. - In: RESPIRATION. - ISSN 0025-7931. - ELETTRONICO. - (2017). [10.1159/000475843]

Conventional versus Ultrasound-Guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymph Adenopathies: A Randomized Controlled Trial

BONIFAZI, MARTINA;MEI, FEDERICO;SEDIARI, MICHELE;GASPARINI, STEFANO
2017-01-01

Abstract

BACKGROUND: Conventional transbronchial needle aspiration (c-TBNA) and endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are both valuable diagnostic techniques for the diagnosis of hilar/mediastinal lesions. Although a superiority of EBUS-TBNA over c-TBNA may be expected, evidence-based data on a direct comparison between these 2 procedures are still lacking. OBJECTIVES: We aimed to test the superiority of EBUS-TBNA over c-TBNA in a randomized trial and to evaluate the cost-effectiveness profile of a staged strategy, including c-TBNA as initial test followed by EBUS-TBNA, in case of inconclusive results at rapid on-site evaluation. METHODS: Eligible patients were randomized 1:1 to either the EBUS-TBNA or c-TBNA group. The primary endpoint was to test the superiority of EBUS-TBNA sensitivity over c-TBNA. The secondary endpoints included the sensitivity of the staged strategy, as well as costs and safety related to each procedure and to their sequential combination. RESULTS: A total of 253 patients were randomized to either EBUS-TBNA (n = 127) or c-TBNA (n = 126), and 31 patients of the c-TBNA group subsequently underwent EBUS-TBNA. The sensitivity of EBUS-TBNA was higher, but not significantly superior to that of c-TBNA (respectively. 92% [95% CI 87-97] and 82% [95% CI 75-90], p > 0.05). The sensitivity of the staged strategy was 94% (95% CI 89-98). No major adverse events occurred. CONCLUSIONS: EBUS-TBNA was the single best diagnostic tool, although not significantly superior to c-TBNA. Due to the favorable cost-effectiveness profile of their sequential combination, in selected scenarios with a high probability of success from the standard procedure, these should not be necessarily intended as competitive and the staged strategy could be considered in clinical practice.
2017
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11566/250125
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