Mediastinal Lymphadenopathy Clinical Trial
Official title:
The Study for Diagnostic Value and Safety of Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in Mediastinal Lesions
Verified date | October 2022 |
Source | Third Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.
Status | Completed |
Enrollment | 271 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 90 Years |
Eligibility | Inclusion Criteria: - Age >=15 years; - More than one mediastinal lesions with diameter >= 1cm was detected by thoracic CT; - Indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ; - Completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions; - Informed consent form achievement. Exclusion Criteria: - Contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on; - Failure to detect the mediastinal lesions in ultrasonic landscape; - Cysts or abscess; - Requirements for additional procedures other than EBUS examination (such as endobronchial biopsy); - Psychiatric disorders or severe neurosis. - Participation in other clinical experiments in recent 3 months; - Any other conditions considered to be inappropriate to be involved in this study. |
Country | Name | City | State |
---|---|---|---|
China | The Army Medical University | Chongqing | Chongqing |
Germany | Thoraxklinik - Heidelberg University Hospital | Heidelberg | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Third Military Medical University | Heidelberg University |
China, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | diagnostic yield | percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm | through study completion, an average of 1 year | |
Primary | prevalence of the procedure-related adverse events | the ratio of the number of patients who had adverse events caused by the procedure and the number of all the patients who have undergone this procedure in each arm | through study completion, an average of 1 year | |
Secondary | sample size | the area and diameter of sample obtained by each procedure | through study completion, an average of 1 year | |
Secondary | consumed time | duration of each period in each procedure | through study completion, an average of 1 year | |
Secondary | sample adequacy | the ratio of the number of patients with adequate sample by the procedure and the number of all the patients who have undergone this procedure | through study completion, an average of 1 year |
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