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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
156
Participants with lymphadenopathy would receive EBUS-TBNA attempts to conduct diagnoses.
Participants with lymphadenopathy would receive EBUS-TBMC via a tunnel attempts to conduct diagnoses.
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Diagnostic yield
The proportion of all individuals undergoing the diagnostic procedure under evaluation in whom a specific diagnosis was established. All the final diagnosis in this trial were established by the treating clinician and verified by an independent diagnosis verification panel which included three pulmonary and critical care medicine physicians, one radiologist, and one pathologist.
Time frame: 6 months after the biopsy
Diagnostic sensitivity
The proportion of individuals who truly had the disease and tested positive.
Time frame: 6 months after biopsy.
Incidence rate of adverse events
Symptoms and signs
Time frame: 7 days after the biopsy
Size of specimen
measurement
Time frame: during the procedure
Specimen quality
questionnaire
Time frame: during the procedure
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