Tunneled Pleural Catheter in Partially Entrapped Lung

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Pleural Effusion

Intervention / Treatment
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* Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage
* Procedure: VATS, Talc-pleurodesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: One-sided malignant pleural effusion, first occurrence, or following repeated pleuracentesis History of dyspnea relieved after pleuracentesis Patient is suitable for VATS Surgery is indicated by diagnostic necessity Ability of subject to understand character and individual consequences of clinical trial Written informed consent must be available before enrolment in the trial For women with childbearing potential, adequate contraception. Histological proven pleural carcinosis by immediate sectioning Intraoperative: partial entrapment of the lung Exclusion Criteria: Prior lobectomy or pneumonectomy on the affected side The patient is not operable for general reasons or Karnofsky performance score < 50 Intraoperative suspicion of a pleural empyema Chylothorax Prior attempts at pleurodesis Intended or prior intrapleural chemotherapy or radiotherapy Pregnancy and lactation Participation in other competing clinical trials and observation period of competing trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Implantation of PleurX-Pleural catheter plus talc pleurodesis | Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage<br>* poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter<br>* Other names: Device: PleurX-Pleural Catheter;|
| Active Comparator: 2<br>talc pleurodesis, no implantation of PleurX-Pleural catheter | Procedure: VATS, Talc-pleurodesis<br>* poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter<br>* Other names: no PleurX-Pleural Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global quality scale QL2 |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis) |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant pleural effusion, subcutaneous tunneled drainage, talc pleurodesis