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The goal of this clinical trial is to clear the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (TBMC) via a tunnel. The main questions it aims to answer are:
Does EBUS-TBMC via a tunnel have a superior diagnostic yield to EBUS-transbronchial needle aspiration (TBNA)? When EBUS-TBMC via a tunnel could be performed as a first-line diagnostic tool in patients with mediastinal and/or hilar lymphadenopathy?
Researchers will compare EBUS-TBMC via a tunnel to EBUS-TBNA to see if EBUS-TBMC via a tunnel has a superior of diagnostic yield with a well-tolerance.
Participants will:
Recieve EBUS-TBMC via a tunnel and EBUS-TBNA in a predefined sequence. Recieve chest CT examination and follow-up for 7 days after procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBMC via a tunnel first group | Experimental | After completing the routine bronchoscopy examination, under the EBUS guidance, combined with the results of chest CT to determine the location of puncture. Then, a disposable puncture dilation catheter (BroncTru AK-91-55; Broncus Inc., Hangzhou, China) was inserted through the working channel of the ultrasound bronchoscope and built a tunnel between the airway wall and targeted lymph node. The 1.1-mm cryoprobe (Erbe 20402-401; ERBE, Tübingen, Germany) was inserted into the target lymph node through the tunnel under direct EBUS monitoring, and the distance between the tip of the cryoprobe and the border of the target lymph node was measured using EBUS. After confirming that the distance was >5 mm, the probe was cooled with liquid carbon dioxide for 5-9 seconds and freezing 3 times to obtain 3 pieces of sample. At the end of TBMC via a tunnel, EBUS-TBNA is performed in the same lymph node, and the tissue is aspirated repeatedly for 5 strokes (one stroke is 30 round trips). |
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| EBUS-TBNA first group | Experimental | Completion of routine bronchoscopy, determination of the puncture position under EBUS guidance, combined with the results of chest CT, and application of the EBUS-TBNA needle to repeatedly aspirate the tissue for 5 strokes (one stroke is 30 round trips ). At the end of the puncture, EBUS-TBMC via a tunnel was then performed with a freezing time of 5-9 seconds (1.1-mm cryoprobe), and frozen 3 times to obtain 3 pieces of samples. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS-TBNA | Procedure | Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis was established. All the final diagnosis in this trial were established by the treating clinician and verified by an independent diagnosis verification panel which included three pulmonary and critical care medicine physicians, one radiologist, and one pathologist. | 6 months after the biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic sensitivity | The proportion of individuals who truly had the disease and tested positive. | 6 months after biopsy. |
| Incidence rate of adverse events | Symptoms and signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Hou, MD | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41592566 | Derived | Deng M, Zheng Z, Zhang X, Xia Y, Tang F, Yang Z, Zhong C, Tong R, Zhou G, Li X, Zhao L, Dai H, Hou G. EBUS-guided transbronchial mediastinal cryobiopsy for diagnosing non-metastatic lymphadenopathy: A randomized controlled trial. Med. 2026 Feb 13;7(2):100962. doi: 10.1016/j.medj.2025.100962. Epub 2026 Jan 26. |
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| EBUS-TBMC via a tunnel | Procedure | Participants with lymphadenopathy would receive EBUS-TBMC via a tunnel attempts to conduct diagnoses. |
|
| 7 days after the biopsy |
| Size of specimen | measurement | during the procedure |
| Specimen quality | questionnaire | during the procedure |