Comparing three biopsy techniques for diagnosing lymph node issues
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.
This study is testing three different biopsy methods to see which one works best and is safest for people with swollen lymph nodes in the chest area.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 552 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06262620 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the diagnostic effectiveness and safety of three different biopsy techniques—EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel—in patients with mediastinal or hilar lymphadenopathy. Participants will be randomly assigned to one of the three groups and will undergo the respective biopsy procedure. The study will assess both the diagnostic yield and the occurrence of any adverse events associated with each technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with at least one hilar or mediastinal lesion requiring a diagnostic bronchoscopy.
Not a fit: Patients with mediastinal cysts, abscesses, or severe comorbidities that contraindicate bronchoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve diagnostic accuracy and safety for patients with mediastinal lymphadenopathy.
How similar studies have performed: Previous studies have shown varying success with similar biopsy techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Gang Hou, MD — China-Japan Friendship Hospital
- Study coordinator: Gang Hou, MD
- Email: hougangcmu@163.com
- Phone: 010-84205729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.