Sarcoidosis, Pulmonary
Conditions
Keywords
Endobronchial Ultrasound, EBUS-TBNA, EBUS-transbronchial mediastinal cryobiopsy, Sarcoidosis
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEBUS-TBNA-based sampling methods
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.
PROCEDUREEBUS-TBMC based sampling method
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18years; 2. Patients with clinical and radiological suspicion of stage I or stage II sarcoidosis; 3. Fully informed of the purpose and method of the study
Exclusion criteria
1. Pathologically confirmed sarcoidosis, obvious organ involvement with the possibility of confirming granulomas using a minimally invasive diagnostic procedure; 2. Patients with medical contraindications to bronchoscopy procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The granuloma detection rate | 7 days after sampling | The number of patients with granulomas detected relative to the total number of patients tested. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | 6 Month after sampling | The proportion of all participants who underwent the diagnostic procedure in whom a specific malignant or benign diagnosis was established |
| Negative predictive value | 6 months after sampling | — |
| Incidence of complications | 4 weeks after sampling | — |
Countries
China
Outcome results
None listed