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

Last updated: August 24, 2024
Sponsor: China-Japan Friendship Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

EBUS-TBCB

EBUS-TTCB

EBUS-TBFB

Clinical Study ID

NCT06262620
2022-NHLHCRF-LX-01-0201-06
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years;

  • At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnosticbronchoscopy procedure;

  • Patients who can understand the purpose of the trial, participate voluntarily andsign an informed consent form.

Exclusion

Exclusion Criteria:

  • The lesion is a mediastinal cyst or abscess;

  • Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance toanaesthesia, combined psychiatric disorders or severe neurosis and other relevantcontraindications to bronchoscopy;

  • EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a largevessel, etc. Consider biopsy to be high risk and inappropriate for continuation ofbiopsy;

  • EBUS did not detect lesions in the hilum and/or mediastinum;

  • Those who, in the judgement of the investigator, have poor patient compliance andare unable to complete the study as required due to mental disorders, etc.

Study Design

Total Participants: 552
Treatment Group(s): 7
Primary Treatment: EBUS-TBCB
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
February 18, 2026

Connect with a study center

  • China-Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Active - Recruiting

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