Clinical trial · Observational
Relationship Between Pleural Elastance and Effectiveness of Pleurodesis on Recurrent Malignant Pleural Effusion
NCT01819363CI-TRIAL-00009844unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 with RMPE. The secondary objectives of this study are: correlate pleural elastance with quality of life, analysis of dyspnea and pain after the procedure, clinical effectiveness, complications and mortality in 30 days.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pleural Effusion, Malignant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pleural elastance | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- Patients with Malignant pleural effusion according to inclusion and exclusion criteria.
- interventionNames
- Procedure: Pleural elastance
Primary outcomes (1)
- measure
- Radiological Effective
- timeFrame
- 1 month after the inclusion
- description
- The effectiveness will be measured by radiographic tomography of the chest. Will be measured volumes of pleural fluid in chest CT after placement of the drain and 1 month after pleurodesis
Secondary outcomes (5)
- measure
- Clinical Effectiveness
- timeFrame
- 1 months after inclusion; each 3 months after inclusion until death
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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).
References
Publications (0)
Data not yet available
No reference posted for this study.