Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06262620

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

Led by China-Japan Friendship Hospital · Updated on 2024-08-27

552

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • At least one hilar or mediastinal lymph node lesion with short axis 1 cm or larger requiring diagnostic bronchoscopy
  • Ability to understand the trial purpose, willing to participate voluntarily, and able to sign informed consent form
Not Eligible

You will not qualify if you...

  • Lesion is a mediastinal cyst or abscess
  • Severe cardiopulmonary diseases, coagulation disorders, poor anesthesia tolerance, psychiatric disorders, severe neurosis, or other contraindications to bronchoscopy
  • Lesion is rich in blood flow or adjacent to large vessels making biopsy high risk
  • No lesions detected in hilum or mediastinum by EBUS
  • Poor patient compliance or mental disorders preventing study completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

Actively Recruiting

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Research Team

G

Gang Hou, MD

CONTACT

M

Mingming Deng, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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