The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.

Not Applicable

Recruiting

• Conditions: Lymphadenopathy Hilar; Lymphadenopathy Mediastinal
• Interventions: Procedure: EBUS-TBFB via a tunnel; Procedure: EBUS-TBNA; Procedure: EBUS-TBMC via a tunnel

• Registration Number: NCT06262620
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel) in mediastinal/hilar lymph node biopsies.

Participants will divided into EBUS-TBNA group, EBUS-TBMC via a tunnel group, and EBUS-TBFB via a tunnel group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBMC via a tunnel, or EBUS-TBFB according to the group.

Researchers will compare the diagnostic yield and incidence of adverse events of the three biopsy techniques.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-16
• Study Start: 2024-03-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-24
• Last Update Posted: 2024-08-27
• Primary Completion: 2026-02-18
• Study Completion: 2026-02-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 552

Inclusion Criteria

• Age ≥ 18 years;
• At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure;
• Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.

Exclusion Criteria

• The lesion is a mediastinal cyst or abscess;
• Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy;
• EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy;
• EBUS did not detect lesions in the hilum and/or mediastinum;
• Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBUS-transbronchial forceps biopsy via a tunnel	EBUS-TBFB via a tunnel	Participants would undertake EBUS-transbronchial forceps biopsy via a tunnel.
EBUS-transbronchial needle aspiration	EBUS-TBNA	Participants would undertake EBUS-transbronchial needle aspiration.
EBUS-transbronchial mediastinal cryobiopsy via a tunnel	EBUS-TBMC via a tunnel	Participants would undertake EBUS-transbronchial mediastinal cryobiopsy via a tunnel.

Primary Outcome Measures

Name	Time	Method
Incidence rate of adverse events	7 days after the biopsy	Symptoms and signs
the adequacy of sample acquisition	7 days after the biopsy	Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.
Dignostic yield of EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB	7 days after the biopsy	The proportion of participants in whom the biopsy led to a definitive diagnosis.

Secondary Outcome Measures

Name	Time	Method
the adequacy of sample acquisition	7 days after the biopsy	Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China