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| Name | Class |
|---|---|
| Becton, Dickinson and Company | INDUSTRY |
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This is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. Patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. Patients will be followed up for 3 months post intervention
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | Active Comparator | Patients in this group will be managed as per the British Thoracic Society guideline for management of malignant pleural effusions. They will undergo chest tube insertion and undergo Talc pleurodesis with 4g of SteriTalc |
|
| Indwelling Pleural Catheter Group | Active Comparator | Patients in this group will undergo Indwelling Pleural Catheter (IPC) insertion. This will be inserted as per standard practice. They will undergo Talc pleurodesis via the IPC with 4g SteriTalc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest Drain Insertion and Talc Pleurodesis | Device |
| ||
| Indwelling Pleural Catheter Insertion and Talc Pleurodesis |
| Measure | Description | Time Frame |
|---|---|---|
| Global health-related quality of life | Global health related quality of life as measured by EORTC QLQ-C30 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Global health-related quality of life | 60 and 90 days | |
| Pleurodesis failure rate | Subsequent pleural intervention required on same side as pleurodesis Chest X-ray opacification greater than 25% on side of intervention |
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Inclusion Criteria:
Exclusion Criteria:
Age less than 18 years old
Pregnant or lactating
Known allergy to Talc or Lignocaine
Lack of symptomatic relief from effusion drainage
At least twice weekly drainage cannot be undertaken
Lymphoma or small cell carcinoma except*:
Non malignant effusions
Loculated pleural effusion
Unable to provide written informed consent to trial participation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
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| Device |
|
| 30, 60 and 90 days |
| Improvement in symptoms of pain and breathlessness | Medical Research Council (MRC) dyspnoea scale 100mm Visual Analog Scale for pain and breathlessness | 30, 60 and 90 days |
| Complication rate | Clinical review and adverse event documentation | Day 7, 14, 30, 60 and 90 |
| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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