Status:
COMPLETED
Tunneled Pleural Catheter in Partially Entrapped Lung
Lead Sponsor:
Heidelberg University
Conditions:
Malignant Pleural Effusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 e...
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 ins...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00637676
Start Date
July 1 2008
End Date
September 1 2011
Last Update
September 2 2022
Active Locations (1)
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1
Thoraxklinik, University of Heidelberg
Heidelberg, Germany, 69126