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A single center, prospective, cohort controlled clinical study evaluating ultrasound-guided transbronchial mediastinal lymph node frozen biopsy combined with pathological rapid on-site assessment for the diagnosis of lung cancer

A single center, prospective, cohort controlled clinical study evaluating ultrasound-guided transbronchial mediastinal lymph node frozen biopsy combined with pathological rapid on-site assessment for the diagnosis of lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103314
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Lung cancer

Interventions

Test group:Ultrasound-guided transbronchial mediastinal lymph node frozen biopsy combined with pathological rapid on-site assessment
Control group:Surgical removal of mediastinal lymph nodes using mediastinoscopy or thoracoscopy

Sponsors

Shanghai Pulmonary Hospital, Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Chest enhanced CT suggests the presence of lung shadows and mediastinal lymph node enlargement. Imaging suggests the possibility of lung cancer, but no definitive diagnosis has been made. Clinically, it is considered a newly diagnosed patient with the possibility of lung cancer; 2. The patient is unable to obtain tissue for pathological diagnosis through routine bronchoscopy brushing or biopsy, and no cancer cells were found in sputum examination; 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-3 points; 4. Electrocardiogram, heart function, lung function, blood routine, and coagulation indicators are all normal; 5. No other organic diseases that affect the operation; 6. Can tolerate general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Clear diagnosis of lung cancer patients; 2. Patients who have received airway therapy; 3. Patients with airway obstruction who cannot undergo bronchoscopy examination; 4. Expected survival period<1 month; 5. The shortest diameter of mediastinal lymph nodes is less than 1cm; 6. Mediastinal lymph nodes are located in areas that cannot be sampled by EBUS; 7. Abnormal blood coagulation or other hemorrhagic diseases; 8. Existence of active infectious diseases; 9. Having serious heart function or other organic diseases; 10. Patients with systemic infections; 11. There are contraindications to anesthesia; 12. Breastfeeding or pregnant women; 13. There are uncontrollable mental illnesses; 14. Patients who have participated or are currently participating in clinical trials of other drugs or devices before enrollment; 15. Other situations assessed by researchers as unsuitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Pathological analysis;Genetic testing;Molecular detection;

Secondary

MeasureTime frame
Economic cost;

Countries

China

Contacts

Public ContactJun Zhu

Shanghai Pulmonary Hospital, Tongji University School of Medicine

rotor121@sina.com+86 139 1703 6595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026