Tunneled Pleural Catheter in Partially Entrapped Lung
|Malignant Pleural Effusion||Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage Procedure: VATS, Talc-pleurodesis||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Tunneled Pleural Catheter Versus Standard Chest Tube in Management of Malignant Pleural Effusion in Patients With Partial Entrapment of the Lung|
- global quality scale QL2 [ Time Frame: 3 months ]
- clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis) [ Time Frame: 3 months ]
|Study Start Date:||July 2008|
|Study Completion Date:||September 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Implantation of PleurX-Pleural catheter plus talc pleurodesis
Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage
poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter
Other Name: Device: PleurX-Pleural Catheter
Active Comparator: 2
talc pleurodesis, no implantation of PleurX-Pleural catheter
Procedure: VATS, Talc-pleurodesis
poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter
Other Name: no PleurX-Pleural Catheter
Patients with malignant pleural effusions undergo VATS-procedure. In the intraoperative finding of a partially entrapped lung, patients are randomized in 2 groups.
Arm 1: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery.
Arm 2: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery. Additionally, a subcutaneous tunneled catheter will be inserted and will remain in situ
Follow up period is 3 Months
Primary objective is the comparison of quality of life between the 2 arms.
Secondary objective is the reliability of the subcutaneous tunnelled catheter in practice as well as function and dysfunction of the drainage system. Clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis) are observed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637676
|Thoraxklinik, University of Heidelberg|
|Heidelberg, Germany, 69126|
|Principal Investigator:||Hans Hoffmann, MD, PhD||Thoraxklinik, University of Heidelberg|