The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.
Recruiting now · Not applicable
Conditions studied: Lymphadenopathy Hilar, Lymphadenopathy Mediastinal
In brief
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.
Key facts
- Study ID
- NCT06262620
- Run by
- China-Japan Friendship Hospital
- People needed
- 552
- Starts
- 2024-03-01
- Expected to finish
- 2026-02-18
- Last updated by the study team
- 2024-08-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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