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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBMC | Experimental | Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBMC |
|
| EBUS-TBNA | Experimental | Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBNA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS-TBNA-based sampling methods | Procedure | Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The granuloma detection rate | The number of patients with granulomas detected relative to the total number of patients tested. | 7 days after sampling |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | The proportion of all participants who underwent the diagnostic procedure in whom a specific malignant or benign diagnosis was established | 6 Month after sampling |
| Negative predictive value |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41856756 | Derived | Zheng Z, Wang H, Guo J, Zhang Q, Tang F, Xu L, Deng MM, Herth F, Poletti V, Hou G. Diagnostic Value of EBUS-guided Transbronchial MEdiastinal Cryobiopsy versus ConvenTIONal Bronchoscopic Approaches for Intrathoracic Stage I/II SARcoidosis: protocol for a randomised controlled trial (DETECTION-SAR-II). BMJ Open Respir Res. 2026 Mar 19;13(1):e004065. doi: 10.1136/bmjresp-2025-004065. |
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| EBUS-TBMC based sampling method | Procedure | Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC. |
|
| 6 months after sampling |
| Incidence of complications | 4 weeks after sampling |
| ID | Term |
|---|---|
| D017565 | Sarcoidosis, Pulmonary |
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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