China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Location status: Recruiting
Recruiting
NCT Number: NCT06262620
The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
EBUS-TBNA
ProcedureA 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.
Other names: Endobronchial ultrasound-guided transbronchial needle aspiration.
EBUS-TBMC via a tunnel
ProcedureFirst 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.
Other names: endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy via a tunnel.
EBUS-TBFB via a tunnel
ProcedureFirstly, 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 names: endobronchial ultrasound-guided transbronchial forceps biopsy
Primary outcomes
-
Dignostic yield of EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB
Time frame: 7 days after the biopsy
The proportion of participants in whom the biopsy led to a definitive diagnosis.
-
Incidence rate of adverse events
Time frame: 7 days after the biopsy
Symptoms and signs
-
the adequacy of sample acquisition
Time frame: 7 days after the biopsy
Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.
Secondary outcomes
-
the adequacy of sample acquisition
Time frame: 7 days after the biopsy
Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate.
Study contacts
Contact information is provided by the study sponsor or research team.
Gang Hou, MD
CONTACT
Mingming Deng, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
China-Japan Friendship Hospital
Other
Registry information
Official study title
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.
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 16, 2024
- Registry last updated
- Aug 27, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.