Clinical trial · Interventional
Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter
Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter on the Incidence of Auto-Pleurodesis in Patients With Malignant Pleural Effusions
- 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)
Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency of pleural drainage and, if so, whether catheter-related complications can be minimized and spare patients the need for long term management of the Pleurx® catheter.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aggressive Drainage Instructions | Other | — | UNRESOLVED |
| Standard Drainage Instructions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aggressive Drainage Arm
- description
- Patients will drain up to 1 liter of pleural fluid everyday
- interventionNames
- Other: Aggressive Drainage Instructions
- type
- ACTIVE_COMPARATOR
- label
- Standard Drainage Arm
- description
- Patients will drain up to 1 liter of pleural fluid every other day
- interventionNames
- Other: Standard Drainage Instructions
Primary outcomes (1)
- measure
- To compare the incidence of auto-pleurodesis utilizing aggressive drainage versus standard drainage protocols with the PleuRx® catheter
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age greater than 18 years old 2. Pleural effusion (etiology fulfilling one of the following criteria): * Malignant effusion confirmed by cytology or pleural biopsy * Exudative effusion in the setting of known malignancy with no other identifiable cause * Malignant effusion due to tumors that are historically rapidly responsive to systemic therapy (small cell lung cancer, hematological malignancies) will only be included if refractory to standard chemotherapy 3. Symptoms such as shortness of breath, cough, or chest fullness/chest discomfort 4. Age greater than 18 years old 5. Pleural effusion (etiology fulfilling one of the following criteria): * Demonstration of symptomatic improvement after therapeutic thoracentesis (removal of ≤ 1.5 L of pleural fluid) * Recurrent pleural effusion after therapeutic thoracentesis Exclusion Criteria: 1. Projected life expectancy less than 30 days as predicted by Karnofsky Performance Status score less than 30 2. Radiographic evidence of trapped lung - persistent lung collapse with failure of the lung to reexpand following drainage of a pleural effusion 3. Radiographic evidence of loculated pleural fluid 4. Previous attempted pleurodesis on the affected side 5. Previous lobectomy or pneumonectomy on the affected side 6. Patient receiving intrapleural chemotherapy 7. Chylothorax - pleural effusion with triglyceride levels \> 110 mg/dl or chylomicrons on lipoprotein analysis, most commonly due to trauma/obstruction of the thoracic duct 8. Parapneumonic effusion - pleural effusion associated with pneumonia 9. Empyema - infected pleural space as defined by purulent pleural fluid, positive gram stain, or positive culture 10. Inability to adequately perform pleural drainage at home 11. Uncorrectable bleeding disorder 12. Skin infection at the site of intended catheter insertion 13. Pregnancy
References
Publications (3)
- BACKGROUNDTremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest. 2006 Feb;129(2):362-368. doi: 10.1378/chest.129.2.362. PMID 16478853
- BACKGROUNDMusani AI, Haas AR, Seijo L, Wilby M, Sterman DH. Outpatient management of malignant pleural effusions with small-bore, tunneled pleural catheters. Respiration. 2004 Nov-Dec;71(6):559-66. doi: 10.1159/000081755. PMID 15627865
- BACKGROUNDBarkauskas CE, Wahidi MM. Rate of auto pleurodesis with the indwelling pleural catheter using an aggressive drainage protocol in patients with malignant pleural effusions. Submitted for American Thoracic Society 2006 Meeting.