NCT05803239

Study on Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Via a Tunnel in the Diagnosis of Mediastinal Lymphadenopathy

The Diagnostic Yield and Safety of Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel in Mediastinal Lymphadenopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to clear the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (TBMC) via a tunnel. The main questions it aims to answer are: Does EBUS-TBMC via a tunnel have a superior diagnostic yield to EBUS-transbronchial needle aspiration (TBNA)? When EBUS-TBMC via a tunnel could be performed as a first-line diagnostic tool in patients with mediastinal and/or hilar lymphadenopathy? Researchers will compare EBUS-TBMC via a tunnel to EBUS-TBNA to see if EBUS-TBMC via a tunnel has a superior of diagnostic yield with a well-tolerance. Participants will: Recieve EBUS-TBMC via a tunnel and EBUS-TBNA in a predefined sequence. Recieve chest CT examination and follow-up for 7 days after procedure.

Conditions

• Mediastinal Lymphadenopathy

Interventions

Type	Name	Description
PROCEDURE	EBUS-TBNA	Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.
PROCEDURE	EBUS-TBMC via a tunnel	Participants with lymphadenopathy would receive EBUS-TBMC via a tunnel attempts to conduct diagnoses.

Timeline

• Start date: 2023-02-18
• Primary completion: 2025-03-18
• Completion: 2025-03-18
• First posted: 2023-04-07
• Last updated: 2025-07-20

Locations

1 site across 1 country: China