Diagnostic Value of EBUS-Guided Transbronchial Mediastinal Cryobiopsy Versus Conventional Bronchoscopic Approaches for Stage I/II Sarcoidosis
August 4, 2026 updated by: Gang Hou, China-Japan Friendship Hospital
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
469
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- China-Japan Friendship Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EBUS-TBMC
Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBMC
|
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBMC.
|
|
Experimental: EBUS-TBNA
Patients will receive endobronchial biopsy, transbronchial lung biopsy and EBUS-TBNA
|
Participants will receive an endobronchial biopsy and a transbronchial lung biopsy, followed by EBUS-TBNA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
7 days after sampling
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic yield
Time Frame: 6 Month after sampling
|
The proportion of all participants who underwent the diagnostic procedure in whom a specific malignant or benign diagnosis was established
|
6 Month after sampling
|
|
Negative predictive value
Time Frame: 6 months after sampling
|
6 months after sampling
|
|
|
Incidence of complications
Time Frame: 4 weeks after sampling
|
4 weeks after sampling
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
November 19, 2025
First Submitted That Met QC Criteria
November 19, 2025
First Posted (Actual)
November 24, 2025
Study Record Updates
Last Update Posted (Actual)
August 6, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DETECTION-SAR-II
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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