Randomized Trial of Tunneled Pleural Catheter Versus Standard Chest Tube in Management of Malignant Pleural Effusion in Patients With Partial Entrapment of the Lung
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
global quality scale QL2
Hans Hoffmann, MD, PhD
Thoraxklinik, University of Heidelberg
Germany:Koordinierungszentrum für klinische Studien, Universitätsklinikum Heidelberg; Voßstr.2;69115 Heidelberg