Clinical trial · Interventional
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
NCT00637676CI-TRIAL-00060659completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VATS, Talc-pleurodesis | Procedure | — | UNRESOLVED |
| VATS, Talc-Pleurodesis, tunneled pleural drainage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Implantation of PleurX-Pleural catheter plus talc pleurodesis
- interventionNames
- Procedure: VATS, Talc-Pleurodesis, tunneled pleural drainage
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- talc pleurodesis, no implantation of PleurX-Pleural catheter
- interventionNames
- Procedure: VATS, Talc-pleurodesis
Primary outcomes (1)
- measure
- global quality scale QL2
- timeFrame
- 3 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDPutnam JB Jr, Walsh GL, Swisher SG, Roth JA, Suell DM, Vaporciyan AA, Smythe WR, Merriman KW, DeFord LL. Outpatient management of malignant pleural effusion by a chronic indwelling pleural catheter. Ann Thorac Surg. 2000 Feb;69(2):369-75. doi: 10.1016/s0003-4975(99)01482-4. PMID 10735665
- BACKGROUNDTremblay A, Mason C, Michaud G. Use of tunnelled catheters for malignant pleural effusions in patients fit for pleurodesis. Eur Respir J. 2007 Oct;30(4):759-62. doi: 10.1183/09031936.00164706. Epub 2007 Jun 13. PMID 17567670
- BACKGROUNDTremblay A, Michaud G. Single-center experience with 250 tunnelled pleural catheter insertions for malignant pleural effusion. Chest. 2006 Feb;129(2):362-368. doi: 10.1378/chest.129.2.362. PMID 16478853
- RESULTHarzheim D, Sterman D, Shah PL, Eberhardt R, Herth FJ. Bronchoscopic Transparenchymal Nodule Access: Feasibility and Safety in an Endoscopic Unit. Respiration. 2016;91(4):302-6. doi: 10.1159/000445032. Epub 2016 Mar 24. PMID 27007334