Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Recurrence of pleural effusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
VATS hyperthermic pleural chemoperfusion
The patients undergo a VATS drainage of pleural effusion with adhesiolysis and complete mobilization of the lung, following by a 1 hour hyperthermic (40oC)chemoperfusion by means of a pump machine.
Intervention: VATS hyperthermic chemoperfusion (Procedure)
Bedside talc slurry pleurodesis
The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed.
Intervention: Bedside talc slurry pleurodesis (Procedure)
Outcomes
Primary Outcomes
Recurrence of pleural effusion
Time Frame: 2 months following intervention
Secondary Outcomes
- Morbidity(Postoperative period (7 days following intervention))
Investigators
Nikolaos Barbetakis
Head of Thoracic Surgery Department
Theagenio Cancer Hospital