Using cryobiopsy to diagnose mediastinal lymphadenopathy
The Diagnostic Yield and Safety of Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel in Mediastinal Lymphadenopathy
This study is testing a new way to take tissue samples from the chest to see if it works better and is safer than the usual method for diagnosing swollen lymph nodes in the chest.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (BeiJing, Beijing) |
| Trial ID | NCT05803239 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) via a tunnel compared to the traditional EBUS-transbronchial needle aspiration (TBNA). Participants will undergo both procedures in a predefined sequence, followed by a chest CT examination and a 7-day follow-up. The study seeks to determine if EBUS-TBMC via a tunnel can serve as a first-line diagnostic tool for patients with mediastinal and/or hilar lymphadenopathy.
Who should consider this trial
Good fit: Ideal candidates include patients with mediastinal and/or hilar lymphadenopathy requiring diagnostic bronchoscopy, without known or suspected primary lung cancer.
Not a fit: Patients with mediastinal cysts or abscesses, or those with certain medical conditions that pose a high risk for the procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more accurate and safer diagnostic method for patients with mediastinal lymphadenopathy.
How similar studies have performed: While the specific approach of EBUS-TBMC via a tunnel is novel, similar techniques have shown promise in improving diagnostic yields in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) in the absence of a known or suspected primary lung cancer, requiring diagnostic bronchoscopy. * The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBMC via a tunnel before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc. * There was no contraindication of puncture and cryobiopsy. * Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form. Exclusion Criteria: * The lesion is a mediastinal cyst or abscess. * The patient is allergic to lidocaine and midazolam. * The site to be biopsied has a high risk of bleeding detected by Doppler and/or contrast CT such as bronchial artery penetration or suspected lung metastasis of renal cancer. * Unstable angina pectoris, congestive heart failure, severe bronchial asthma * The patient did not agree to participate in this study * Participation in other studies within three months without withdrawal or termination will affect the observation of this study * The researcher believes that there is any person who is not suitable for the selection
Where this trial is running
BeiJing, Beijing
- China-Japan Friendship Hospital — BeiJing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Gang Hou, MD — China-Japan Friendship Hospital
- Study coordinator: Mingming Deng, MD
- Email: isdeng1017@163.com
- Phone: 86 18801336854
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.