Mediastinal Lymphadenopathy
Conditions
Brief summary
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.
Detailed description
A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used to be compared. The patients involved were randomly divided into two groups. In the experimental group, EBUS-TBMCB was performed following EBUS-TBNA while in the other group, EBUS-TBNA was performed respectively. The samples obtained in the two groups were analyzed by the pathologists. Patients were followed up for confirming the diagnosis and complications. The diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.
Interventions
PROCEDUREEBUS-TBMCB
endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA
Sponsors
Heidelberg University
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic yield | through study completion, an average of 1 year | percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm |
| prevalence of the procedure-related adverse events | through study completion, an average of 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sample size | through study completion, an average of 1 year | the area and diameter of sample obtained by each procedure |
| consumed time | through study completion, an average of 1 year | duration of each period in each procedure |
| sample adequacy | through study completion, an average of 1 year | 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 |
Countries
China, Germany
Outcome results
None listed