Malignant Pleural Effusion
Conditions
Brief summary
Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.
Detailed description
Background： Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients. Methods: A unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. Consecutive 183 patients were randomly assigned to two groups, A group is Bevacizumab200mg by intrapleural administration; B group is injected pulvis talci with closed thoracic drainage.
Interventions
DRUGBevacizumab
Bevacizumab200mg by intrapleural administration
DRUGPulvis talci
Pulvis talci 4g by intrapleural administration
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnose malignant pleural effusions by: * Diagnose malignant pleural neoplasms by histopathology * Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer 2. Written informed consent
Exclusion criteria
1. \<18years of age 2. Expected survival \<3 months 3. Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once 4. Planned chemotherapy 5. Pregnancy or breast-feeding (women of child-bearing potential) 6. Not signed informed consent or non-compliance with treatment protocols
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in chest drainage | up to 3months | Observed chest drainage every day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the average daily VAS defining breathlessness | up to 1 year | VAS: Visual Analogue Scale |
| Average daily thoracalgia assessed using VAS score | up to 1 year | VAS: Visual Analogue Scale |
| percentage of adverse reactions | up to 1 year | — |
| Length of Stay | up to 1 year | — |
Countries
China
Contacts
Primary Contactxiaofei li, doctor
Outcome results
None listed