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Diagnostic value and safety of combined biopsy for mediastinal metastasis of lung cancer

Diagnostic value and safety of ebus-tbna combined with mediastinal cryobiopsy for mediastinal metastasis of lung cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128928
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-03-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mediastinal metastasis of lung cancer

Interventions

Experimental group:Following the completion of EBUS-TBNA, EBUS-guided transbronchial mediastinal cryobiopsy (EBUS-TBMCB) will be performed.
Control group:Endobronchial ultrasound–guided transbronchial needle aspiration (EBUS-TBNA) will be performed.

Sponsors

The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. 80 years >= Age >= 18 years; 2. Presence of at least one mediastinal lesion (short-axis diameter =10 mm) confirmed by thin-slice chest CT; 3. For clinically suspected or confirmed lung cancer requiring mediastinal staging, biopsy is necessary to determine the etiology or pathological subtype; 4. Patients must have completed all required preoperative laboratory tests and necessary examinations (e.g., cardiac ultrasound, CTA) to rule out contraindications; 5. Patients are informed and capable of providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of severe cardiopulmonary disease, coagulation disorders, massive hemoptysis, poor tolerance to anesthesia, or other contraindications related to bronchoscopy; 2. Intraoperative endobronchial ultrasound exploration of the lesion failed to detect the target lesion despite > 20 minutes of attempts; 3. Lesions identified as abscesses or cysts; 4. Presence of mental illness, severe neurosis, or other conditions that preclude the provision of informed consent; 5. Patients who have participated in other clinical trials within 3 months; 6. Any other conditions considered to be inappropriate to be involved in this trial.

Design outcomes

Primary

MeasureTime frame
Diagnostic yield for lung cancer;

Secondary

MeasureTime frame
Diagnostic accuracy;Sample adequacy;Suitability for molecular assays;Duration of bronchoscopic procedure;Incidence of procedure-related adverse events;Sample size;

Countries

China

Contacts

Public ContactFan Ye

The Second Affiliated Hospital of Third Military Medical University (Xinqiao Hospital)

83728087@qq.com+86 139 8381 5728

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026