Malignant Pleural Effusion
Conditions
Keywords
malignant pleural effusion, subcutaneous tunneled drainage, talc pleurodesis
Brief 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.
Interventions
PROCEDUREVATS, Talc-Pleurodesis, tunneled pleural drainage
poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter
PROCEDUREVATS, Talc-pleurodesis
poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| global quality scale QL2 | 3 months |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed