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

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Lymphadenopathy Mediastinal; Lymphadenopathy Hilar

Treatments: Procedure: EBUS-TBMC via a tunnel; Procedure: EBUS-TBNA; Procedure: EBUS-TBFB via a tunnel

Study type: Interventional

Funder types: Other

Identifiers

NCT06262620

2022-NHLHCRF-LX-01-0201-06

Details and patient eligibility

About

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.

Enrollment: 552 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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552 participants in 3 patient groups

EBUS-transbronchial needle aspiration

Experimental group

Description:

Participants would undertake EBUS-transbronchial needle aspiration.

Treatment:

Procedure: EBUS-TBNA

EBUS-transbronchial mediastinal cryobiopsy via a tunnel

Experimental group

Description:

Participants would undertake EBUS-transbronchial mediastinal cryobiopsy via a tunnel.

Treatment:

Procedure: EBUS-TBMC via a tunnel

EBUS-transbronchial forceps biopsy via a tunnel

Experimental group

Description:

Participants would undertake EBUS-transbronchial forceps biopsy via a tunnel.

Treatment:

Procedure: EBUS-TBFB via a tunnel