About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18years;
Patients with clinical and radiological suspicion of stage I or stage II sarcoidosis;
Fully informed of the purpose and method of the study
Disqualifiers
Pathologically confirmed sarcoidosis, obvious organ involvement with the possibility of confirming granulomas using a minimally invasive diagnostic procedure;
Patients with medical contraindications to bronchoscopy procedures.
Trial design
Parallel
Treatments tested in this trial
EBUS-TBNA-based sampling methods
Procedure/SurgeryParticipants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.
EBUS-TBMC based sampling method
Procedure/SurgeryParticipants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.
Treatment groups
Trial outcomes
Primary outcomes
The granuloma detection rate
The number of patients with granulomas detected relative to the total number of patients tested.
Secondary outcomes
Diagnostic yield
The proportion of all participants who underwent the diagnostic procedure in whom a specific malignant or benign diagnosis was established
Negative predictive value
Incidence of complications
Locations
Sponsors and contacts
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