Diagnostic Value of EBUS-Guided Transbronchial Mediastinal Cryobiopsy Versus Conventional Bronchoscopic Approaches for Stage I/II Sarcoidosis

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Sarcoidosis, Pulmonary

Treatments: Procedure: EBUS-TBMC based sampling method; Procedure: EBUS-TBNA-based sampling methods

Study type: Interventional

Funder types: Other

Identifiers

NCT07246876

2025-EBUS-TBMC-Sarcoidosis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 469 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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469 participants in 2 patient groups

EBUS-TBMC

Experimental group

Description:

Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBMC

Treatment:

Procedure: EBUS-TBMC based sampling method

EBUS-TBNA

Experimental group

Description:

Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBNA

Treatment:

Procedure: EBUS-TBNA-based sampling methods