Study on Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Via a Tunnel in the Diagnosis of Mediastinal Lymphadenopathy

The Diagnostic Yield and Safety of Endobronchial Ultrasound-guided Mediastinal Cryobiopsy Via a Tunnel in Mediastinal Lymphadenopathy

The goal of this clinical trial is to clear the diagnostic yield and safety of endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (TBMC) via a tunnel. The main questions it aims to answer are:

Does EBUS-TBMC via a tunnel have a superior diagnostic yield to EBUS-transbronchial needle aspiration (TBNA)? When EBUS-TBMC via a tunnel could be performed as a first-line diagnostic tool in patients with mediastinal and/or hilar lymphadenopathy?

Researchers will compare EBUS-TBMC via a tunnel to EBUS-TBNA to see if EBUS-TBMC via a tunnel has a superior of diagnostic yield with a well-tolerance.

Participants will:

Recieve EBUS-TBMC via a tunnel and EBUS-TBNA in a predefined sequence. Recieve chest CT examination and follow-up for 7 days after procedure.

Inclusion Criteria:

• Patients with at least one mediastinal and/or hilar lymphadenopathy (≥1cm in the short axis) in the absence of a known or suspected primary lung cancer, requiring diagnostic bronchoscopy.
• 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.
• There was no contraindication of puncture and cryobiopsy.
• Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form.

Exclusion Criteria:

• The lesion is a mediastinal cyst or abscess.
• The patient is allergic to lidocaine and midazolam.
• 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.
• Unstable angina pectoris, congestive heart failure, severe bronchial asthma
• The patient did not agree to participate in this study
• Participation in other studies within three months without withdrawal or termination will affect the observation of this study
• The researcher believes that there is any person who is not suitable for the selection