Diagnostic Value and Safety of Combined Biopsy for Mediastinal Metastasis of Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThird Military Medical University
About this trial
The study is aimed o evaluate the diagnostic performance and treatment guidance of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) combined with transbronchial mediastinal cryobiopsy (EBUS-TBMCB) in patients with mediastinal metastases of lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years;
Presence of at least one mediastinal lesion (short-axis diameter ≥10 mm) confirmed by thin-slice chest CT;
Disqualifiers
Presence of severe cardiopulmonary disease, coagulation disorders, massive hemoptysis, poor tolerance to anesthesia, or other contraindications related to bronchoscopy;
Intraoperative endobronchial ultrasound exploration of the lesion failed to detect the target lesion despite > 20 minutes of attempts;
Lesions identified as abscesses or cysts;
Presence of mental illness, severe neurosis, or other conditions that preclude the provision of informed consent;
Trial design
Design model
Parallel
Treatments tested in this trial
EBUS-TBMCB
Procedure/SurgeryEndobronchial ultrasound-guided transbronchial mediastinal cryobiopsy will be performed in experimental arm following EBUS-TBNA
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: EBUS-TBNANo intervention 0 interventions
Group B: EBUS-TBNA plus EBUS-TBMCBExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic yield for lung cancer
For each biopsy modality, diagnostic yield for lung cancer is defined as the percentage of patients with eventually confirmed lung cancer (by histopathology/cytology or long-term follow-up) in whom the initial biopsy using that modality established the diagnosis.
Time frame
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 monthsSecondary outcomes
1
Diagnostic accuracy
Diagnostic accuracy was defined as the proportion of patients whose initial test results are consistent with the final diagnosis, based on histopathological/cytological findings and long-term follow-up assessment
Time frame
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months2
Sample size
The area and diameter of samples obtained by each procedure
Time frame
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months3
Suitability for molecular assays
Suitability of NSCLC samples for molecular assays
Time frame
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 months4
Duration of bronchoscopic procedure
The duration of each specific step from the start to the end of the biopsy
Time frame
From the date of biopsy sample acquisition to the date of follow-up completion, approximately 12 monthsSponsors and contacts
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Source ClinicalTrials.gov