Tunneled Pleural Catheter in Partially Entrapped Lung
Germany50 participantsStarted 2008-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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