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Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VATS hyperthermic pleural chemoperfusion | Active Comparator | 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. |
|
| Bedside talc slurry pleurodesis | Active Comparator | The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VATS hyperthermic chemoperfusion | Procedure | VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of pleural effusion | 2 months following intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Postoperative period (7 days following intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaos Barbetakis, MD, PhD | Theagenio Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoracic Surgery Department, Theagenio Cancer Hospital | Thessaloniki | 54007 | Greece |
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| Bedside talc slurry pleurodesis | Procedure | Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis. |
|
| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
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