The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
84
thoracoscopy with semirigid instrument
thoracoscopy with rigid instrument
University Clinic Golnik
Golnik, Golnik, Slovenia
diagnostic adequacy of semirigid thoracoscopy
* comparison of diagnostic adequacy of both instruments (number of definitive diagnosis in each group) * size of the biopsy specimens in mm2 * interpretability of biopsy specimens in histopathology terms: 1. easily interpretable (enough tissue with all elements required for diagnosis) 2. interpretable with some difficulty (less tissue or diagnostic elements - diagnosis less reliable) 3. interpretable with great difficulty (little tissue or scarce diagnostic elements - low reliability of diagnosis) 4. non-interpretable (diagnosis not possible)
Time frame: 12 months
safety
Major adverse events: * bleeding * infection * reexpansion pulmonary edema Minor adverse events: * transient self-limited fever * pain * prolongued air leak * subcutaneous emphysema 30-day mortality
Time frame: 1 month
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