Sarcoidosis, PulmonaryNCT07246876
Diagnostic Value of EBUS-Guided Transbronchial Mediastinal Cryobiopsy Versus Conventional Bronchoscopic Approaches for Stage I/II Sarcoidosis
A study testing EBUS-TBNA-based sampling methods and EBUS-TBMC based sampling method in people with Sarcoidosis, Pulmonary, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary
- What is being tested?
- EBUS-TBNA-based sampling methods and EBUS-TBMC based sampling method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 469 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to Dec 2026
- 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 ≥18years;
- Patients with clinical and radiological suspicion of stage I or stage II sarcoidosis;
- Fully informed of the purpose and method of the study
Who cannot join
- Pathologically confirmed sarcoidosis, obvious organ involvement with the possibility of confirming granulomas using a minimally invasive diagnostic procedure;
- Patients with medical contraindications to bronchoscopy procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. However, a direct comparison between them has not been conducted. This randomized controlled trial aims to compare directly the diagnostic yield between EBUS-TBMC and EBUS-TBNA+EBB+TBLB in sarcoidosis.
Read the detailed description
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. However, a direct comparison between them has not been conducted. Two questions remain need to be answered: (1) Does EBUS-TBMC have the same or better diagnostic sensitivity for sarcoidosis than EBUS-TBNA combined with standard bronchoscopic modalities (EBB or/and TBLB)? (2) Can combining EBUS-TBMC with standard bronchoscopic modalities further increase the diagnostic sensitivity for sarcoidosis? This study is designed as a randomised controlled trial to compare the diagnostic yield between EBUS-TBMC and conventional bronchoscopic approaches for diagnosing stage I/II sarcoidosis.
- Conditions
- Sarcoidosis, Pulmonary
- Being tested
- EBUS-TBNA-based sampling methods, EBUS-TBMC based sampling method
- Keywords
- Endobronchial Ultrasound, EBUS-TBNA, EBUS-transbronchial mediastinal cryobiopsy, Sarcoidosis
- Medical subject headings
- Sarcoidosis, Pulmonary, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBUS-TBNA-based sampling methodsProcedure or surgery
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.
EBUS-TBMC based sampling methodProcedure or surgery
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.
| Study group | Role | What they receive |
|---|---|---|
| EBUS-TBMC | Experimental | Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBMC Receives: Procedure: EBUS-TBMC based sampling method |
| EBUS-TBNA | Experimental | Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBNA Receives: Procedure: EBUS-TBNA-based sampling methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
The granuloma detection rate
The number of patients with granulomas detected relative to the total number of patients tested.
Measured: 7 days after sampling
Secondary outcomes (3)
Diagnostic yield
The proportion of all participants who underwent the diagnostic procedure in whom a specific malignant or benign diagnosis was established
Measured: 6 Month after sampling
Negative predictive value
Measured: 6 months after sampling
Incidence of complications
Measured: 4 weeks after sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Mar 2026
- Primary completion1 Nov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoidosis, PulmonaryStudies 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
- 469 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246876
- Sponsor's protocol ID
- DETECTION-SAR-II
- Status last verified
- Aug 2026
- First submitted
- 19 Nov 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng Z, Wang H, Guo J, Zhang Q, Tang F, Xu L, Deng MM, Herth F, Poletti V, Hou G. Diagnostic Value of EBUS-guided Transbronchial MEdiastinal Cryobiopsy versus ConvenTIONal Bronchoscopic Approaches for Intrathoracic Stage I/II SARcoidosis: protocol for a randomised controlled trial (DETECTION-SAR-II). BMJ Open Respir Res. 2026 Mar 19;13(1):e004065. doi: 10.1136/bmjresp-2025-004065.
PubMed 41856756
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of EBUS-Guided Transbronchial Mediastinal Cryobiopsy Versus Conventional Bronchoscopic Approaches for Stage I/II Sarcoidosis
- ClinicalTrials.gov ID
- NCT07246876
- Acronym / sponsor ID
- DETECTION-SAR-II
- Conditions
- Sarcoidosis, Pulmonary
- Keywords
- Endobronchial Ultrasound, EBUS-TBNA, EBUS-transbronchial mediastinal cryobiopsy, Sarcoidosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 469 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Nov 2025 (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.
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. However, a direct comparison between them has not been conducted. This randomized controlled trial aims to compare directly the diagnostic yield between EBUS-TBMC and EBUS-TBNA+EBB+TBLB in sarcoidosis.
Detailed description
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), combined with endobronchial biopsy (EBB) and/or transbronchial lung biopsy (TBLB), and endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) have high diagnostic yields for patients with sarcoidosis. However, a direct comparison between them has not been conducted. Two questions remain need to be answered: (1) Does EBUS-TBMC have the same or better diagnostic sensitivity for sarcoidosis than EBUS-TBNA combined with standard bronchoscopic modalities (EBB or/and TBLB)? (2) Can combining EBUS-TBMC with standard bronchoscopic modalities further increase the diagnostic sensitivity for sarcoidosis? This study is designed as a randomised controlled trial to compare the diagnostic yield between EBUS-TBMC and conventional bronchoscopic approaches for diagnosing stage I/II sarcoidosis.
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-TBMC based sampling methodPatients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBMC |
| EBUS-TBNA | Experimental | Procedure: EBUS-TBNA-based sampling methodsPatients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18years;
- Patients with clinical and radiological suspicion of stage I or stage II sarcoidosis;
- Fully informed of the purpose and method of the study
Key exclusion criteria (2 listed)
- Pathologically confirmed sarcoidosis, obvious organ involvement with the possibility of confirming granulomas using a minimally invasive diagnostic procedure;
- Patients with medical contraindications to bronchoscopy procedures.
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-TBNA-based sampling methodsParticipants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA. | Procedure or surgery | EBUS-TBNA |
| EBUS-TBMC based sampling methodParticipants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC. | Procedure or surgery | EBUS-TBMC |
Primary outcome
The granuloma detection rate
Time frame: 7 days after sampling
The number of patients with granulomas detected relative to the total number of patients tested.
3 secondary outcomes
Diagnostic yield
Time frame: 6 Month after sampling
Negative predictive value
Time frame: 6 months after sampling
Incidence of complications
Time frame: 4 weeks after sampling
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 6 Aug 2026.
- Derived from this study: PubMed 41856756Zheng Z, Wang H, Guo J, Zhang Q, Tang F, Xu L, Deng MM, Herth F, Poletti V, Hou G. Diagnostic Value of EBUS-guided Transbronchial MEdiastinal Cryobiopsy versus ConvenTIONal Bronchoscopic Approaches for Intrathoracic Stage I/II SARcoidosis: protocol for a randomised controlled trial (DETECTION-SAR-II). BMJ Open Respir Res. 2026 Mar 19;13(1):e004065. doi: 10.1136/bmjresp-2025-004065.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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-TBNA-based sampling methods and EBUS-TBMC based sampling method in people with Sarcoidosis, Pulmonary, 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The granuloma detection rate (time frame: 7 days after sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07246876, which also lists 1 linked publication.
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 6 Aug 2026.