Cryobiopsy or Forceps Biopsy During Semirigid Thoracoscopy: a Comparative Study
NCT ID: NCT01475084
Last Updated: 2015-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2011-11-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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Cryobiopsy, forceps biopsy
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.
cryobiopsy (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.
Interventions
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cryobiopsy (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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* unstable cardiovascular status
* severe heart failure
* ECOG performance status 4
* persistent hypoxemia after evacuation of pleural fluid
* pleural symphisis, fibrothorax
18 Years
ALL
No
Sponsors
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The University Clinic of Pulmonary and Allergic Diseases Golnik
OTHER
Responsible Party
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Aleš Rozman
MD
Principal Investigators
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Ales Rozman, MD
Role: PRINCIPAL_INVESTIGATOR
University Clinic Golnik
Locations
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University Clinic Golnik
Golnik, Golnik, Slovenia
Countries
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Other Identifiers
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Endo-0003
Identifier Type: -
Identifier Source: org_study_id
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