Tunneled Pleural Catheter in Partially Entrapped Lung
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|ClinicalTrials.gov Identifier: NCT00637676|
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : September 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Effusion||Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage Procedure: VATS, Talc-pleurodesis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||September 2011|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637676
|Thoraxklinik, University of Heidelberg|
|Heidelberg, Germany, 69126|
|Principal Investigator:||Hans Hoffmann, MD, PhD||Thoraxklinik, University of Heidelberg|