The efficacy of sonographic and biological pleurodesis indicators of malignant pleural effusion (SIMPLE)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Participants are randomly allocated to one of two groups: Intervention group: Participants receive thoracic ultrasound imaging before and post talc administration. Control group: Participants receive talc pleurodesis with no thoracic ultrasound imaging. CONDITION: Topic: Cancer, Respiratory disorders; Subtopic: Lung Cancer, Respiratory (all Subtopics); Disease: Lung (small cell), Lung (non‐small cell), Lymphoma (Hodgkin's), Lymphoma (non‐Hodgkin's), Mesothelioma, Respiratory, Lymphoma (Non Hodgkins ‐ aggressive), Lymphoma (Non Hodgkins ‐ indolent), Lymphoma (other) ; Cancer ; Malignant pleural effusion PRIMARY OUTCOME: Length of hospital stay (in days) during the initial hospitalisation SECONDARY OUTCOME: 1. Mortality rate is recorded at 12 months; 2. Number of days in hospital post‐randomisation with drain in situ; 3. Patient reported dysponea/chest pain post‐randomisation is measured through daily assessments for 7 days and then weekly for 4 weeks; 4. Patient reported quality of life is measured using the EQ‐5D‐5L questionnaire at baseline, 1 and 3 months; 5. Pleurodesis success is determined at 1 and 3 months; 6. Use of healthcare resources and costs using utilisation logs is measured as discharge, 1 and 3 months INCLUSION CRITERIA: 1. Clinically confident diagnosis of MPE requiring pleurodesis defined as any of the following (more than one can be included): 1.1. Histocytologically proven MPE 1.2. Thoracic CT evidence of pleural malignancy 1.3. Otherwise unexplained exudative effusion in the context of clinically proven cancer elsewhere 2. Written informed consent
Epistemonikos ID: c52ae6fe83760c57c58ed6f8c3e7d400e1d7fc13
First added on: Aug 24, 2024