Pleural Diseases, Pleural Effusion
Conditions
Keywords
Flex-rigid pleuroscopy, cryobiopsy, pleural biopsy, pleural effusion, safety, thoracoscopy
Brief summary
The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.
Detailed description
The investigators are going to compare diagnostic yield and size, morphological features, immunohistochemistry as measures of the quality of the samples. The secondary aim is to evaluate safety with focus on bleeding intensity.
Interventions
DEVICEcryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps
The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline. Forceps biopsy will be performed on usual way.
Sponsors
The University Clinic of Pulmonary and Allergic Diseases Golnik
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 or more years old * unilateral pleural effusion of unknown origin * pleural irregularities suspicious for pleural malignancy * referral for thoracoscopy after less invasive means of diagnosis had failed
Exclusion criteria
* uncontrolled bleeding tendency * unstable cardiovascular status * severe heart failure * ECOG performance status 4 * persistent hypoxemia after evacuation of pleural fluid * pleural symphisis, fibrothorax
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of forceps biopsy and cryobiopsy samples | 12 month | * diagnostic yield * 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) * assessment of biopsy-related artifacts by describing the amount of unaltered tissue in quartiles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 1 month | The degree of bleeding at the biopsy site will be assessed as 1 = slight, self-limited, 2 = moderate, requiring electrocautery intervention, 3 = severe, requiring interruption of the procedure, chest tube drainage and intravenous fluid resusucitation. |
Countries
Slovenia
Outcome results
None listed