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NCT07459569
Diagnostic Performance and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy in Diagnosing Tuberculous Mediastinal Lymphadenitis: a Randomised Controlled Trial
NA trial testing EBUS-TBMC in Tuberculosis in 108 participants. Not yet recruiting.
1 May 2027
Quick facts
| Lead sponsor | China-Japan Friendship Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 108 |
| Start date | 1 May 2026 |
| Primary completion | 1 May 2027 |
| Estimated completion | 1 May 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- EBUS-TBMC
- EBUS-TBNA
Conditions studied
- Tuberculosis — all drugs for Tuberculosis →
- Mediastinal and Hilar Lymph Node Enlargement — all drugs for Mediastinal and Hilar Lymph Node Enlargement →
Sponsor
China-Japan Friendship Hospital
Who can join
18 and older, any sex, with Tuberculosis or Mediastinal and Hilar Lymph Node Enlargement. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Granuloma Detection Rate
Time frame: Within 2 weeks post-procedure (upon completion of histopathological processing and reporting)
The proportion of patients in whom granulomatous inflammation is detected on histopathological examination of the biopsy specimens obtained from the target mediastinal lymph node. Assessment will be performed by pathologists blinded to the biopsy technique used for each specimen.
Sponsor's own description
The goal of this clinical trial is to compare the diagnostic efficacy and safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy (EBUS-TBMC) versus standard EBUS-guided Transbronchial Needle Aspiration (EBUS-TBNA) in adult patients with suspected mediastinal lymph node tuberculosis. The main questions it aims to answer are: Does EBUS-TBMC provide a superior diagnostic yield for detecting granulomatous inflammation compared to EBUS-TBNA in the same target lymph node? Does the cryopreservation process affect the viability of Mycobacterium tuberculosis for culture, and does the larger tissue sample obtained via EBUS-TBMC enhance the sensitivity of molecular tests such as Xpert MTB/RIF? Is the safety profile of EBUS-TBMC, particularly regarding bleeding complications, comparable to that of EBUS-TBNA in this patient population? Researchers will compare the two biopsy techniques using a paired design within the same patient to see if EBUS-TBMC results in higher rates of positive pathology, microbiology, and molecular diagnoses. Participants will: Undergo both EBUS-TBNA and EBUS-TBMC procedures on the same mediastinal lymph node during a single bronchoscopy session, with the order of procedures randomized. Provide blood and tissue samples for comprehensive testing, including histology, mycobacterial culture, and Xpert MTB/RIF assay. Complete short-term (within 2 hours post-procedure) and 7-day follow-up assessments to monitor for any adverse events. Participate in a 6-month clinical follow-up to establish a final diagnosis, which will serve as the reference standard for evaluating the diagnostic tests.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07459569
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07459569 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China-Japan Friendship Hospital
- Last refreshed: 5 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07459569.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing