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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryobiopsy | Experimental | Biopsies will be obtained by flexible autoclavable cryoprobe 20416-032 (Erbokryo CA, ERBE, Germany) with 2.4 mm in diameter. The tip of the probe is cooled to -890C with nitrous oxide within seconds after footswitch activation. The biopsy sample will by extracted by gently pulling of the probe. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryobiopsy (Autoclavable cryoprobe 20416-032) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe | To determine, wheather cryobiopsy specimen can be obtained in each patient | 12 months |
| Size of biopsy samples | Size of the biopsy specimens in mm2 | 12 months |
| Quality of the sample | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | 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. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ales Rozman, MD | University Clinic Golnik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Golnik | Golnik | Golnik | 4204 | Slovenia |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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