Status:
COMPLETED
Pleural Cryobiopsies During Semirigid Thoracoscopy: A New Technique
Lead Sponsor:
The University Clinic of Pulmonary and Allergic Diseases Golnik
Conditions:
Pleural Effusion
Pleural Diseases
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 di...
Eligibility Criteria
Inclusion
- 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
- Uncontrolled bleeding tendency
- Unstable cardiovascular status
- Severe heart failure
- ECOG performance status 4
- Persistent hypoxemia after evacuation of pleural fluid
- Pleural symphisis, fibrothorax
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01472172
Start Date
February 1 2010
End Date
November 1 2013
Last Update
December 5 2013
Active Locations (1)
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1
University Clinic Golnik
Golnik, Golnik, Slovenia, 4204