Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Les… (NCT04572984) | Clinical Trial Compass
CompletedNot Applicable
Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in the Diagnosis of Mediastinal Lesions
China, Germany271 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range15 Years – 90 Years
SexALL
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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.
What they're measuring
1
diagnostic yield
Timeframe: through study completion, an average of 1 year
2
prevalence of the procedure-related adverse events
Timeframe: through study completion, an average of 1 year