Diagnostic Performance and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy in Diagnosing Tuberculous Mediastinal Lymphadenitis: a Randomised Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EBUS-TBMC, EBUS-TBNA.
- Who it may be relevant to
- Registry conditions: Tuberculosis, Mediastinal and Hilar Lymph Node Enlargement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure EBUS-TBMC
EBUS-TBMC is a minimally invasive bronchoscopic procedure performed under moderate sedation or general anesthesia to obtain larger and more intact tissue samples from mediastinal lymph nodes compared to conventional needle aspiration. A convex probe EBUS scope is used to identify the target lymph node, and Doppler mode is employed to map vascular structures for safe puncture path planning. A dedicated puncture dilation catheter is inserted under real-time EBUS guidance to puncture the airway wal - Procedure EBUS-TBNA
EBUS-TBNA is a standard minimally invasive bronchoscopic procedure performed under moderate sedation or general anesthesia to obtain cytological samples from mediastinal lymph nodes. A convex probe EBUS scope is used to identify the target lymph node, and Doppler mode is employed to map vascular structures for safe puncture path planning. A dedicated 22G EBUS aspiration needle is inserted under real-time ultrasound guidance to puncture the airway wall and enter the target lymph node. Standard "t
Primary outcome measures
- Granuloma Detection Rate [Time frame: Within 2 weeks post-procedure (upon completion of histopathological processing and reporting)]
Secondary outcome measures (4)
- Mycobacterium tuberculosis Culture Positivity Rate [Time frame: Up to 6 weeks post-procedure (standard mycobacterial culture reporting time)]
- Acid-Fast Bacilli (AFB) Smear Positivity Rate [Time frame: Within 1 week post-procedure]
- Xpert MTB/RIF Ultra Positivity Rate [Time frame: Within 3 days post-procedure]
- Procedure-Related Complication Rate [Time frame: From start of procedure through 7 days post-procedure]
Eligibility criteria
Inclusion criteria
- Age 18 years or older;
- Presence of unexplained mediastinal lymphadenopathy (short-axis diameter ≥1 cm on chest computed tomography) with clinical suspicion of tuberculosis;
- Completion of routine pre-procedural evaluations including blood tests (complete blood count, coagulation profile), electrocardiogram, and chest CT;
- Absence of contraindications for EBUS-TBNA or EBUS-TBMC procedures;
- Provision of written informed consent after being fully informed of the study purpose and procedures.
Exclusion criteria
- Known allergy to lidocaine or midazolam;
- Presence of bronchial artery penetration into the target lesion or high risk of bleeding as detected by contrast-enhanced CT or EBUS Doppler mode prior to the procedure;
- Unstable angina, congestive heart failure, or severe bronchial asthma;
- Evidence of significant liquefaction necrosis in the target mediastinal lymph node on pre-procedural CT or EBUS;
- Patient refusal to participate in the study;
- Participation in another clinical trial within the past three months that may interfere with the outcomes of this study;
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- 2nd Yinghuadong Street, Beijing, China — Beijing
Identifiers
NCT: NCT07459569 · DETECTION-LYM-TB