Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare cryobiopsies with forceps biopsies during semirigid thoracoscopy.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryobiopsy, forceps biopsy | Experimental | Cryoiopsies 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. Forceps biopsies will be obtained by flexible FB-55CD-1 Olympus forceps. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps | 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. Forceps biopsy will be performed on usual way. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of forceps biopsy and cryobiopsy samples |
| 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 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. | 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided