The Comparison of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration, Mediastinal Cryobiopsy Via a Tunnel, and Forceps Biopsy Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy: a Multicenter Randomised Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphadenopathy Hilar
- Sponsor
- China-Japan Friendship Hospital
- Enrollment
- 552
- Locations
- 1
- Primary Endpoint
- Incidence rate of adverse events
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Gang Hou
Principal Investigator
China-Japan Friendship Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Incidence rate of adverse events
Time Frame: 7 days after the biopsy
Symptoms and signs
the adequacy of sample acquisition
Time Frame: 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
Time Frame: 7 days after the biopsy
The proportion of participants in whom the biopsy led to a definitive diagnosis.
Secondary Outcomes
- the adequacy of sample acquisition(7 days after the biopsy)