The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.
The Comparison of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration, Mediastinal Cryobiopsy Via a Tunnel, and Forceps Biopsy Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy: a Multicenter Randomised Controlled Trial.
1 other identifier
interventional
552
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2024
CompletedFirst Posted
Study publicly available on registry
February 16, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2026
CompletedAugust 27, 2024
August 1, 2024
2 years
February 1, 2024
August 24, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
the adequacy of sample acquisition
7 days after the biopsy
Study Arms (3)
EBUS-transbronchial needle aspiration
EXPERIMENTALParticipants would undertake EBUS-transbronchial needle aspiration.
EBUS-transbronchial mediastinal cryobiopsy via a tunnel
EXPERIMENTALParticipants would undertake EBUS-transbronchial mediastinal cryobiopsy via a tunnel.
EBUS-transbronchial forceps biopsy via a tunnel
EXPERIMENTALParticipants would undertake EBUS-transbronchial forceps biopsy via a tunnel.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years;
- 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.
You may not qualify if:
- The lesion is a mediastinal cyst or abscess;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Related Publications (1)
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.
PMID: 40987727DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Gang Hou, MD
China-Japan Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 1, 2024
First Posted
February 16, 2024
Study Start
March 1, 2024
Primary Completion
February 18, 2026
Study Completion
February 18, 2026
Last Updated
August 27, 2024
Record last verified: 2024-08