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 determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. The secondary aim is to evaluate safety with focus on bleeding intensity.
Detailed description
The primary aim of this study is to determine feasibility of pleural biopsies with the cryoprobe during semirigid thoracoscopy. We will assess size, morphological features, immunohistochemistry and diagnostic yield 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)
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.
Sponsors
The University Clinic of Pulmonary and Allergic Diseases Golnik
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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 |
|---|---|---|
| Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe | 12 months | To determine, wheather cryobiopsy specimen can be obtained in each patient |
| Size of biopsy samples | 12 months | Size of the biopsy specimens in mm2 |
| Quality of the sample | 12 months | 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 |
|---|---|---|
| Bleeding | 1 month | Number of patients with a certain degree of bleeding from biopsy site, described 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