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Clinical Trial Summary

An open randomized, prospective, single center; parallel group trial to compare efficiency and safety of PleurX-Pleural Catheter versus standard surgical treatment in patients with malignant pleural effusion and partial entrapment of the lung.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT00637676
Study type Interventional
Source Heidelberg University
Contact
Status Completed
Phase Phase 2
Start date July 2008
Completion date September 2011

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