Cost Effectiveness, Efficacy of Intervention, Safety of Intervention
Conditions
Keywords
Pleural effusion, VATS, hyperthermia, thoracostomy, pleurodesis
Brief summary
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.
Detailed description
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.
Interventions
PROCEDUREVATS hyperthermic chemoperfusion
VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)
PROCEDUREBedside talc slurry pleurodesis
Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.
Sponsors
Theagenio Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of pleural effusion | 2 months following intervention |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity | Postoperative period (7 days following intervention) |
Countries
Greece
Outcome results
None listed