Clinical trial · Interventional
Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS
Randomized Clinical Trial to Evaluate the Efficacy of the Permanent Thoracic Catheter (Pleur-X) Towards Pleurodesis in Thoracoscopy in the Treatment of Malignant Pleural Effusion
- 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)
This is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (Pleur-X) versus chemical pleurodesis in videothoracoscopy (VATS) in the treatment of malignant pleural effusion at the first diagnosis.Patients with malignant pleural effusion for whom there is indication of surgery and who agree to participate in the study will be randomized 1: 1 in the Pleur-X arm (arm 1) or in the chemical pleurodesis arm (arm 2). The arm 1 provides for the installation of a permanent drainage under local anesthesia while the arm 2 provides a pleurodesis with talc in VATS under general anesthesia. Both procedures are standard of care.
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 |
|---|---|---|---|
| Pleurodesis | Procedure | — | UNRESOLVED |
| Pleur-X | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pleur-X
- description
- Placement of a permanent drainage under local anesthesia
- interventionNames
- Procedure: Pleur-X
- type
- EXPERIMENTAL
- label
- pleurodesis
- description
- Pleurodesis with talc in VATS
- interventionNames
- Procedure: Pleurodesis
Primary outcomes (1)
- measure
- Success rate of the treatment with VPM
- timeFrame
- 4 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years, \<80 years * First diagnosis of malignant pleural effusion * Indication to treat the malignant pleural effusion with surgery * Informed informed consent Exclusion Criteria: * Previous surgeries on the same hemitorace * Pregnant women * Trapped lung syndrome * Patients with estimated life expectancy \< 4-8 weeks
References
Publications (0)
Data not yet available