Mediastinal Lymphadenopathies
Conditions
Keywords
EBUS-TBNA, Confocal laser endomicroscopy, EBUS-TBMC
Brief summary
Comparison of the Diagnostic Yield and Safety Between Confocal Laser Endomicroscopy-Assisted Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration and Endobronchial Ultrasound-Guided Transbronchial Mediastinal Cryobiopsy in patients with mediastinal and/or hilar lymphadenopathy.
Interventions
PROCEDUREConfocal laser endomicroscopy-assisted endobronchial ultrasound-guided transbronchial needle aspiration
First, use the EBUS needle to create a hole in the airway wall. Then, insert the CLE into the lymph node via this hole and detect the lymph node. When the specific pathological finding is detected by CLE, record the location. Finally, using the needle to perform EBUS-TBNA in the area under EBUS guidance.
PROCEDUREEndobronchial ultrsound-guided Mediastinal cryobiopsy
Using the cryoprobe to perform EBUS-TBMC three times per person.
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old 2. Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) without a known or suspected primary lung cancer, required diagnostic bronchoscopy 3. The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBMC via a tunnel before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc 4. There was no contraindication of puncture and cryobiopsy 5. Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.
Exclusion criteria
1. The lesion is a mediastinal cyst or abscess 2. The patient is allergic to lidocaine and midazolam （3) The site to be biopsied has a high risk of bleeding detected by Doppler and/or contrast CT such as bronchial artery penetration or suspected lung metastasis of renal cancer (4) Unstable angina pectoris, congestive heart failure, severe bronchial asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | On day 7 after procedure to obtain the pathological findings. | The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis is established based on the consensus definition. |
Contacts
Primary ContactMingming Deng
Outcome results
None listed