Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. However, a direct comparison between them has not been conducted. This randomized controlled trial aims to compare directly the diagnostic yield between EBUS-TBMC and EBUS-TBNA+EBB+TBLB in sarcoidosis.
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. However, a direct comparison between them has not been conducted. Two questions remain need to be answered: (1) Does EBUS-TBMC have the same or better diagnostic sensitivity for sarcoidosis than EBUS-TBNA combined with standard bronchoscopic modalities (EBB or/and TBLB)? (2) Can combining EBUS-TBMC with standard bronchoscopic modalities further increase the diagnostic sensitivity for sarcoidosis? This study is designed as a randomised controlled trial to compare the diagnostic yield between EBUS-TBMC and conventional bronchoscopic approaches for diagnosing stage I/II sarcoidosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
469
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.
The granuloma detection rate
The number of patients with granulomas detected relative to the total number of patients tested.
Time frame: 7 days after sampling
Diagnostic yield
The proportion of all participants who underwent the diagnostic procedure in whom a specific malignant or benign diagnosis was established
Time frame: 6 Month after sampling
Negative predictive value
Time frame: 6 months after sampling
Incidence of complications
Time frame: 4 weeks after sampling
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