Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
N/A
75 Years
Both
Safety of Intervention, Efficacy of Intervention, Cost Effectiveness
Trial Information
Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
The study compares prospectively two groups of patients with refractory maignant pleural
effusion. Group A consists of patients undergoing video-assisted hyperthermic pleural
chemoperfusion (with a pump machine) and group B includes patients undergoing bed-side tube
thoracostomy and talc slurry pleurodesis.
Inclusion Criteria:
- Recurrent symptomatic malignant pleural effusion
- No prior intrapleural therapy
- Abscence of bronchial obstruction or fibrosis preventing lung reexpansion
- No systemic chemotherapy immediately prior to or during the first 30-day interval
following pleurodesis
Exclusion Criteria:
- Poor Karnofsky Performance Status
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Recurrence of pleural effusion
Outcome Time Frame:
2 months following intervention
Safety Issue:
Yes
Principal Investigator
Nikolaos Barbetakis, MD,PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Consultant Thoracic Surgeon, Thoracic Surgery Department, Theagenio Cancer Hospital
Authority:
Theagenio Cancer Hospital, Ethics Committee,Greece':'
Study ID:
Theagenio Thoracic Surgery 2
NCT ID:
NCT01409551
Start Date:
August 2011
Completion Date:
August 2012
Related Keywords:
- Safety of Intervention
- Efficacy of Intervention
- Cost Effectiveness
- Pleural effusion
- VATS
- hyperthermia
- thoracostomy
- pleurodesis
- Fever
- Pleural Effusion
- Pleural Effusion, Malignant
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