A Prospective, Randomized Controlled Trial for a Rapid Pleurodesis Protocol for the Management of Pleural Effusions
Malignant pleural effusions form a significant proportion of respiratory and oncology work-load. The efficacy of thoracoscopic talc poudrage which is the current standard of care is limited by lung entrapment which prevents lung re-expansion. Thoracoscopy patients also have significant hospital length of stay because chest tube drainage must continue until the pleural space is dry to effect successful pleurodesis.
Alternative management strategies such as tunnelled pleural catheters (bedside ultrasound-guided) enable outpatient management of pleural effusions but have limited pleurodesis rates and do not offer any chance of getting pleural biopsies.
A prospective randomized controlled trial with two arms i.e. thoracoscopic poudrage alone (standard care) versus combined thoracoscopic poudrage and tunnelled pleural catheters. The tunnelled catheters will be inserted at the time of thoracoscopy in the endoscopy centre under ultrasound guidance. The trial is aimed to be completed within 3 years. Primary end-points will be pleurodesis success. The secondary end-points are hospital length-of-stay, complication rates, analgesia requirements, pain scores and quality-of-life scores. Based on power calculations, we aim to recruit 120 patients in each arm.
|Malignant Pleural Effusions||Other: Thoracoscopy and Pleurx Procedure: Thoracoscopy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized Controlled Trial for a Rapid Pleurodesis Protocol for the Management of Pleural Effusions|
- The primary end points will be pleurodesis/pleural catheter success. [ Time Frame: 30 days ]
- Hospital length of stay [ Time Frame: 1 year ]
- Complication rate/analgesia [ Time Frame: 1 year ]
- Quality of life [ Time Frame: 1 year ]
- Talc dose [ Time Frame: 1 year ]
|Study Start Date:||September 2008|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Thoracoscopy with pleurodesis Patients will then undergo standard medical thoracoscopy in the endoscopy center including the use of moderate sedation, prophylactic antibiotics for 1 week and 20F chest tube insertion at the end of the procedure.
Other Name: Pleuroscopy
Combined thoracoscopy with pleurodesis and pleurx catheter. In the combined procedure group, a PleurxTM tunnelled catheter will be inserted under ultrasound guidance. As this procedure will be done concurrently with thoracoscopy, there is no estimated increase in endoscopy time.
Other: Thoracoscopy and Pleurx
Talc poudrage and tunneled pleural catheter
Other Name: Pleuroscopy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00758316
|Sinagpore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Devanand Anantham, FCCP||Singapore General Hospital|