The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.
NCT ID: NCT06262620
Last Updated: 2024-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
552 participants
INTERVENTIONAL
2024-03-01
2026-02-18
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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EBUS-transbronchial needle aspiration
Participants would undertake EBUS-transbronchial needle aspiration.
EBUS-TBNA
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.
EBUS-transbronchial mediastinal cryobiopsy via a tunnel
Participants would undertake EBUS-transbronchial mediastinal cryobiopsy via a tunnel.
EBUS-TBMC via a tunnel
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.
EBUS-transbronchial forceps biopsy via a tunnel
Participants would undertake EBUS-transbronchial forceps biopsy via a tunnel.
EBUS-TBFB via a tunnel
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.
Interventions
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EBUS-TBNA
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.
EBUS-TBMC via a tunnel
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.
EBUS-TBFB via a tunnel
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure;
* Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.
Exclusion Criteria
* Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy;
* EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy;
* EBUS did not detect lesions in the hilum and/or mediastinum;
* Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.
18 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Gang Hou
Principal Investigator
Principal Investigators
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Gang Hou, MD
Role: PRINCIPAL_INVESTIGATOR
China-Japan Friendship Hospital
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2022-NHLHCRF-LX-01-0201-06
Identifier Type: -
Identifier Source: org_study_id
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