mediastinal lesion
Conditions
Interventions
Gold Standard:Pathological diagnosis of tissues obtained through procedures such as ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), mediastinoscopy, or surgical biopsy.
Index test:Experimental group: Sequential implementation of transbronchial needle aspiration (TBNA) and triple-site cryobiopsy of mediastinal lesions under endobronchial ultrasound guidance.
Control
Sponsors
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Thin-slice chest CT indicating at least one mediastinal lesion (short diameter >=10 mm); 3. Newly identified mediastinal lesion, recent onset of respiratory symptoms such as cough, sputum production, chest pain, or shortness of breath, or imaging findings suggesting concurrent pulmonary lesions requiring biopsy to determine the etiology or nature of the mediastinal lesion; 4. Informed consent to participate in this clinical study, with the consent form duly signed.
Exclusion criteria
Exclusion criteria: 1. Presence of severe cardiopulmonary diseases, coagulation disorders, massive hemoptysis, poor anesthesia tolerance, or other contraindications related to bronchoscopy; 2. Preoperative CT indicating that the lesion is adjacent to major blood vessels or vital organs, posing a high procedural risk; 3. Failure to locate the lesion after >20 minutes of exploration using endobronchial ultrasound during the procedure; 4. The lesion is an abscess or cyst; 5. Presence of psychiatric disorders, severe neurosis, or other conditions preventing the provision of informed consent; 6. Participation in another clinical study within the last three months; 7. The etiology of the mediastinal lesion has been definitively determined by other diagnostic or therapeutic methods; 8. Inability to cooperate with the study for any reason or unsuitability for inclusion in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Safety;Clinical Efficacy: Diagnostic Accuracy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic rate of mediastinal mass by EBUS-TBNA biopsy;Diagnostic rate of mediastinal mass by EBUS-TBNA combined with single-point cryobiopsy;Diagnostic rate of mediastinal mass by EBUS-TBNA combined with three-point cryobiopsy;Single-point or three-point cryobiopsy procedure time;Total procedure time of TBNA combined with single-point or three-point cryobiopsy;TBNA puncture complication score (bleeding grading);Cryobiopsy complication score (bleeding grading);Depth of cryoprobe; | — |
Countries
China
Contacts
Public ContactYe Fan
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Outcome results
None listed