Lymphadenopathy Hilar, Lymphadenopathy Mediastinal
Conditions
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.
Interventions
PROCEDUREEBUS-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.
PROCEDUREEBUS-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.
PROCEDUREEBUS-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.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dignostic yield of EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB | 7 days after the biopsy | The proportion of participants in whom the biopsy led to a definitive diagnosis. |
| Incidence rate of adverse events | 7 days after the biopsy | Symptoms and signs |
| the adequacy of sample acquisition | 7 days after the biopsy | Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the adequacy of sample acquisition | 7 days after the biopsy | Samples resulting in a specific diagnosis or samples with the presence of lymphpcytes were considered as adequate. |
Countries
China
Contacts
Primary ContactGang Hou, MD
Backup ContactMingming Deng, PhD
Outcome results
None listed