Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07246876

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
469 (estimated)
Sponsor
China-Japan Friendship Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEBUS-TBNA-based sampling methodsParticipants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.
PROCEDUREEBUS-TBMC based sampling methodParticipants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.

Timeline

Start date
2026-03-01
Primary completion
2026-11-01
Completion
2026-12-01
First posted
2025-11-24
Last updated
2026-02-06

Source: ClinicalTrials.gov record NCT07246876. Inclusion in this directory is not an endorsement.