mediastinal diseases
Conditions
Interventions
Gold Standard:Pathological diagnosis of tissue obtained by ultrasound-guided transbronchial needle aspiration biopsy (EBUS-TBNA) or surgical mediastinoscopic biopsy.
Index test:EBUS-TBNA combined with 1.1mm diameter cryoprobe EBUS-TBCB
EBUS-TBNA combined with 1.7mm diameter cryoprobe EBUS-TBCB
Sponsors
Xinqiao Hospital of Third Military Medical University
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 15; 2. Thin-slice chest CT indicated mediastinal occupation in at least one location (short diameter =10mm); 3. For new mediastinal space occupying, or recent respiratory symptoms such as cough, sputum, chest pain, shortness of breath, or lung lesions associated with imaging findings, biopsy is required to determine the cause or nature of mediastinal space occupying; 4. Improve the routine preoperative tracheoscopy examination, and if necessary, improve cardiac color ultrasound, D2 polymers, CT angiography and other examinations to exclude contraindications; 5. Informed consent to participate in this clinical study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Contraindications related to bronchoscopy such as severe cardiopulmonary disease, coagulation dysfunction, massive hemoptysis, and anesthesia intolerance; 2. Intraoperative ultrasound bronchoscopy explored the lesion >20 minutes, but the lesion was not detected; 3. The lesion is an abscess or cyst; 4. A combination of mental illness or severe neurosis or other inability to provide fully informed consent; 5. The patient participated in other clinical studies within the last 3 months; 6. For any reason, it is not suitable to cooperate with the study or be included in this test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diagnostic yield;operation success rate;diagnostic safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| feasibility;safety;Accuracy ;Sensitivity ;Specificity ;Positive predicative value ;sample size;sample adequacy;operation time; | — |
Countries
China
Contacts
Public ContactFan Ye
Xinqiao Hospital of Third Military Medical University
Outcome results
None listed