Status:
UNKNOWN
Relationship Between Pleural Elastance and Effectiveness of Pleurodesis on Recurrent Malignant Pleural Effusion
Lead Sponsor:
Grupo de Pesquisa em Pleura e Oncologia Toracica
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Pleural Effusion, Malignant
Eligibility:
All Genders
18+ years
Brief Summary
The objective of this study is to analyze the correlation between pleural elastance and the radiological effectiveness (measured by chest tomography) of pleurodesis performed via catheters in patients...
Detailed Description
1. PURPOSE To analyze the correlation between pleural elastance and the radiological effectiveness (measured by chest tomography) of pleurodesis performed via catheters in patients with RMPE. The seco...
Eligibility Criteria
Inclusion
- Malignant pleural effusion diagnosed by pleural fluid cytology and / or pleural biopsy;
- Recurrent pleural effusion (new accumulation of fluid after puncture) and symptoms (dyspnea and / or chest pain);
- Complete lung expansion (\> 90%) after puncture emptying confirmed by chest radiography;
- Karnofsky index (KPS - Karnofsky Performance Status) \> 30;
- Agreed to participate in the study and sign an informed consent.
Exclusion
- Thrombocytopenia or coagulation disorders (prothrombin activity \<50% and platelet count \<80,000 mm3);
- Endobronchial obstruction by the neoplasm;
- Major pulmonary fibrosis or lymphangitis carcinomatosis ipsilateral to the effusion;
- Volume drained \<800 mL;
- No contact between the pleural surfaces after draining;
- Pleural or active systemic infection;
- Massive neoplastic infiltration of the skin;
- Inability to understand the quality of life questionnaire;
- Age less than 18 years;
- Previous pleural procedures (except punctures and needle biopsies).
Key Trial Info
Start Date :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01819363
Start Date
February 1 2012
End Date
January 1 2016
Last Update
March 27 2013
Active Locations (1)
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1
INCOR - Heart Institute
São Paulo, São Paulo, Brazil, 05403-000