Status:
COMPLETED
Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia
Lead Sponsor:
University of Rome Tor Vergata
Conditions:
Pleural Effusion
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence. General anesthesia ...
Eligibility Criteria
Inclusion
- Recurrent pleural effusion at the computed tomography occupying at least 1/3 of the hemithorax in patients with recent history of malignancy.
- Karnofsky performance status ≥ 50
- ASA score II-III
- Acceptance of the randomly assigned anesthesia protocol
- Radiologic evidence of lung re-expansion after previous drainage/thoracentesis
- Absence of blood clotting disorders (INR \< 1.5)
- No contraindications to TEA
- No neurological or psychiatric disturbance contraindicating awake surgery
Exclusion
- Patients refusal of random assignment to treatment arm
- Patients refusal or noncompliance to TEA
- Patients refusal or noncompliance to general anesthesia and one-lung ventilation
- Unfavourable anatomy for TEA
- Previous surgery of the thoracic spine
- Coagulation disorders (thromboplastin time \< 80%, prothrombin time \> 40 sec, platelet count \< 200/nL or bleeding disorders
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01469728
Start Date
November 1 2007
End Date
November 1 2010
Last Update
November 10 2011
Active Locations (1)
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1
Policlinico Tor Vergata University
Rome, Italy, 00133