TuberculosisNCT07459569
Diagnostic Performance and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy in Diagnosing Tuberculous Mediastinal Lymphadenitis: a Randomised Controlled Trial
A study testing EBUS-TBMC and EBUS-TBNA in people with Tuberculosis and Mediastinal and Hilar Lymph Node Enlargement, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Mediastinal and Hilar Lymph Node Enlargement
- What is being tested?
- EBUS-TBMC and EBUS-TBNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
2nd Yinghuadong Street, Beijing, China
Beijing, Beijing Municipality, 100029
Mingming Deng, +86 18801336854, isdeng1017@163.com
About this study
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.
Read more
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.
- Being tested
- EBUS-TBMC, EBUS-TBNA
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBMCProcedure or surgery
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 wall and enter the target lymph node; the needle stylet is then removed, leaving the outer sheath in place to establish a "tunnel" from the airway lumen into the lymph node parenchyma. A flexible cryoprobe is advanced through the sheath into the lymph node, with ultrasound confirmation ensuring the probe tip is positioned within the node while maintaining a safety distance of at least 5 mm from the nodal edge and any visible blood vessels. The freezing system is activated using carbon dioxide as th
EBUS-TBNAProcedure or surgery
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 "to-and-fro" movements are performed approximately 30 times per pass to aspirate cellular material. For this trial, a total of five independent needle passes are performed on the same target node. The specimen from the first pass is collected directly into sterile saline for mycobacterial culture. The remaining specimens are rinsed into 10% neutral buffered formalin for cell block preparation and histopathological evaluation. The rinsing fluid from the needle and specimen container is also collect
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBMC | Experimental | Participants undergoing EBUS-TBMC for suspected mediastinal lymph node tuberculosis. The procedure is performed under moderate sedation or general anesthesia. After locating the target lymph node via EBUS, a tunnel is created using a puncture dilation catheter. The outer sheath is left in place to maintain the tunnel. A cryoprobe is then inserted through the sheath into the lymph node, ensuring the tip is at least 5 mm from the node edge and visible vessels. Freezing is activated using carbon dioxide to obtain tissue samples. A total of three independent cryobiopsy specimens are collected from the same target node. A portion of each specimen is sent for mycobacterial culture and Xpert MTB/RIF testing; the remaining tissue is fixed in formalin for histopathological evaluation. In this paired design study, all participants undergo both EBUS-TBMC and EBUS-TBNA procedures on the same lymph node during a single session, with the sequence determined by randomization. Receives: Procedure: EBUS-TBMC |
| EBUS-TBNA | Active comparator | Participants undergoing standard EBUS-TBNA for suspected mediastinal lymph node tuberculosis. The procedure is performed under moderate sedation or general anesthesia. Using a 22G EBUS aspiration needle, the target lymph node is punctured under real-time ultrasound guidance. Standard "to-and-fro" movements are performed approximately 30 times per pass. A total of five independent needle passes are performed on the same target node. The first pass specimen is collected directly into sterile saline for mycobacterial culture. The remaining specimens are rinsed into formalin for cell block preparation. The rinsing fluid from the needle and specimen container is also collected for Xpert MTB/RIF testing and culture. In this paired design study, all participants undergo both EBUS-TBNA and EBUS-TBMC procedures on the same lymph node during a single session, with the sequence determined by randomization. Receives: Procedure: EBUS-TBNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Granuloma Detection Rate
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.
Measured: Within 2 weeks post-procedure (upon completion of histopathological processing and reporting)
Secondary outcomes (4)
Mycobacterium tuberculosis Culture Positivity Rate
The proportion of patients with a positive culture for Mycobacterium tuberculosis from the biopsy specimens obtained from the target mediastinal lymph node.
Measured: Up to 6 weeks post-procedure (standard mycobacterial culture reporting time)
Acid-Fast Bacilli (AFB) Smear Positivity Rate
The proportion of patients with a positive AFB smear from the biopsy specimens obtained from the target mediastinal lymph node.
Measured: Within 1 week post-procedure
Xpert MTB/RIF Ultra Positivity Rate
The proportion of patients with a positive Xpert MTB/RIF Ultra test result from the biopsy specimens obtained from the target mediastinal lymph node.
Measured: Within 3 days post-procedure
Procedure-Related Complication Rate
The proportion of patients experiencing any adverse event related to the biopsy procedure. This includes, but is not limited to, bleeding (graded according to CHEST consensus criteria), pneumothorax, and mediastinal emphysema.
Measured: From start of procedure through 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Chest Hospital
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459569
- Sponsor's protocol ID
- DETECTION-LYM-TB
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy in Diagnosing Tuberculous Mediastinal Lymphadenitis: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07459569
- Acronym / sponsor ID
- DETECTION-LYM-TB
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- Anhui Chest Hospital
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBMC | Experimental | Procedure: EBUS-TBMCParticipants undergoing EBUS-TBMC for suspected mediastinal lymph node tuberculosis. The procedure is performed under moderate sedation or general anesthesia. After locating the target lymph node via EBUS, a tunnel is created using a puncture dilation catheter. The outer sheath is left in place to maintain the tunnel. A cryoprobe is then inserted through the sheath into the lymph node, ensuring the tip is at least 5 mm from the node edge and visible vessels. Freezing is activated using carbon dioxide to obtain tissue samples. A total of three independent cryobiopsy specimens are collected from the same target node. A portion of each specimen is sent for mycobacterial culture and Xpert MTB/RIF testing; the remaining tissue is fixed in formalin for histopathological evaluation. In this paired design study, all participants undergo both EBUS-TBMC and EBUS-TBNA procedures on the same lymph node during a single session, with the sequence determined by randomization. |
| EBUS-TBNA | Active comparator | Procedure: EBUS-TBNAParticipants undergoing standard EBUS-TBNA for suspected mediastinal lymph node tuberculosis. The procedure is performed under moderate sedation or general anesthesia. Using a 22G EBUS aspiration needle, the target lymph node is punctured under real-time ultrasound guidance. Standard "to-and-fro" movements are performed approximately 30 times per pass. A total of five independent needle passes are performed on the same target node. The first pass specimen is collected directly into sterile saline for mycobacterial culture. The remaining specimens are rinsed into formalin for cell block preparation. The rinsing fluid from the needle and specimen container is also collected for Xpert MTB/RIF testing and culture. In this paired design study, all participants undergo both EBUS-TBNA and EBUS-TBMC procedures on the same lymph node during a single session, with the sequence determined by randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBUS-TBMCEBUS-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 wall and enter the target lymph node; the needle stylet is then removed, leaving the outer sheath in place to establish a "tunnel" from the airway lumen into the lymph node parenchyma. A flexible cryoprobe is advanced through the sheath into the lymph node, with ultrasound confirmation ensuring the probe tip is positioned within the node while maintaining a safety distance of at least 5 mm from the nodal edge and any visible blood vessels. The freezing system is activated using carbon dioxide as th | Procedure or surgery | EBUS-TBMC |
| EBUS-TBNAEBUS-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 "to-and-fro" movements are performed approximately 30 times per pass to aspirate cellular material. For this trial, a total of five independent needle passes are performed on the same target node. The specimen from the first pass is collected directly into sterile saline for mycobacterial culture. The remaining specimens are rinsed into 10% neutral buffered formalin for cell block preparation and histopathological evaluation. The rinsing fluid from the needle and specimen container is also collect | Procedure or surgery | EBUS-TBNA |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBUS-TBMC and EBUS-TBNA in people with Tuberculosis and Mediastinal and Hilar Lymph Node Enlargement, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingming Deng, M.D., Ph.D. (+86 18801336854, isdeng1017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Granuloma Detection Rate (time frame: Within 2 weeks post-procedure (upon completion of histopathological processing and reporting)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.