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The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel) in mediastinal/hilar lymph node biopsies.
Participants will divided into EBUS-TBNA group, EBUS-TBMC via a tunnel group, and EBUS-TBFB via a tunnel group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBMC via a tunnel, or EBUS-TBFB according to the group.
Researchers will compare the diagnostic yield and incidence of adverse events of the three biopsy techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-transbronchial needle aspiration | Experimental | Participants would undertake EBUS-transbronchial needle aspiration. |
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| EBUS-transbronchial mediastinal cryobiopsy via a tunnel | Experimental | Participants would undertake EBUS-transbronchial mediastinal cryobiopsy via a tunnel. |
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| EBUS-transbronchial forceps biopsy via a tunnel | Experimental | Participants would undertake EBUS-transbronchial forceps biopsy via a tunnel. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS-TBNA | Procedure | A 22G biopsy needle was insert into the lesion through tracheal-bronchial wall under real-time EBUS guided by bronchoscopist. Needle punctures were performed by using the jabbing method. Once it is confirmed that the puncture needle is within the target lesion, the puncture needle is moved back and forth while suction (An empty 50 ml syringe was connected to the port at the end of the puncture needle and aspirated to 20 ml maintained for 20 seconds.) is applied. Each lymph node was operated 5 times. |
| Measure | Description | Time Frame |
|---|---|---|
| Dignostic yield of EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB | The proportion of participants in whom the biopsy led to a definitive diagnosis. | 7 days after the biopsy |
| Incidence rate of adverse events | Symptoms and signs | 7 days after the biopsy |
| the adequacy of sample acquisition | Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate. | 7 days after the biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| the adequacy of sample acquisition | Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate. | 7 days after the biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Hou, MD | Contact | 010-84205729 | hougangcmu@163.com | |
| Mingming Deng, PhD | Contact | +86 18801336854 | isdeng@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gang Hou, MD | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | 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. | |
| 40987727 | Derived |
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| EBUS-TBMC via a tunnel | Procedure | First a tunnel between airway wall and mediastinal and/or hilar lesion was made by a puncture dilation catheter (BroncTruTM AK-91-55, Bronchus Inc. Hangzhou, China). The 1.1mm cryoprobe (Erbe 20402-401, ERBE, Tübingen, Germany) entered the target lymph node through the tunnel under direct monitoring of EBUS, and the distance between the tip of the cryoprobe and the border of 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. Then retracted with the bronchoscope and the frozen biopsy tissue. Samples were retrieved by thawing in saline and then fixed in formalin. The same lymph node was operated for 3 times. |
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| EBUS-TBFB via a tunnel | Procedure | Firstly, a tunnel to reach the lymph node is established by making use of a puncture dilation catheter, and a 1.5mm biopsy forceps is pushed into the lymph node through the working channel of the ultrasound bronchoscope. After entering the lymph node, the biopsy forceps were opened proximally to the lymph node, the biopsy forceps were advanced, and then the biopsy forceps were closed distally to the lymph node for each specimen. Each lymph node was operated 5 times. |
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| Deng MM, Yang Z, Zhong C, Zheng Z, Tong R, Zhou G, Li X, Zhao L, Herth FJF, Hou G. Comparison of diagnostic yield and safety of three endobronchial ultrasound-guided transbronchial biopsy techniques in diagnosing patients with mediastinal/hilar lymphadenopathy: a protocol of multicentre randomised trial in China. BMJ Open. 2025 Sep 23;15(9):e096871. doi: 10.1136/bmjopen-2024-096871. |