Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
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|ClinicalTrials.gov Identifier: NCT01472172|
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : December 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion Pleural Diseases||Device: Cryobiopsy (Autoclavable cryoprobe 20416-032)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
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.
Device: Cryobiopsy (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.
Other Name: Autoclavable cryoprobe 20416-032 (ERBE, Germany)
- Number / percent of patients with useful pleural biopsy sample, obtained by cryoprobe [ Time Frame: 12 months ]To determine, wheather cryobiopsy specimen can be obtained in each patient
- Size of biopsy samples [ Time Frame: 12 months ]Size of the biopsy specimens in mm2
- Quality of the sample [ Time Frame: 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
- Bleeding [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472172
|University Clinic Golnik|
|Golnik 36, Golnik, Slovenia, 4204|
|Principal Investigator:||Ales Rozman, MD||University Clinic Golnik|