NCT00637676

Tunneled Pleural Catheter in Partially Entrapped Lung

Randomized Trial of Tunneled Pleural Catheter Versus Standard Chest Tube in Management of Malignant Pleural Effusion in Patients With Partial Entrapment of the Lung

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Malignant Pleural Effusion

Interventions

Type	Name	Description
PROCEDURE	VATS, Talc-Pleurodesis, tunneled pleural drainage	poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter
PROCEDURE	VATS, Talc-pleurodesis	poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-06-01
• Completion: 2011-09-01
• First posted: 2008-03-18
• Last updated: 2022-09-02

Locations

1 site across 1 country: Germany