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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

469 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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. 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.

Conditions

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Sarcoidosis, Pulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EBUS-TBMC

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

Group Type EXPERIMENTAL

EBUS-TBMC based sampling method

Intervention Type PROCEDURE

Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.

EBUS-TBNA

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

Group Type EXPERIMENTAL

EBUS-TBNA-based sampling methods

Intervention Type PROCEDURE

Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.

Interventions

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EBUS-TBNA-based sampling methods

Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.

Intervention Type PROCEDURE

EBUS-TBMC based sampling method

Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No