Malignant Pleural Effusion: Pleur-X vs. Chemical Pleurodesis in VATS
Pleur-X
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
1 other identifier
interventional
234
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2018
CompletedFirst Submitted
Initial submission to the registry
April 6, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 8, 2018
April 1, 2018
2.2 years
April 6, 2018
April 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Success rate of the treatment with VPM
Evaluate the success rate of the treatment with VPM with radiological examination
4 weeks
Secondary Outcomes (3)
Adverse Event
3 months
Quality of live
3 months
Pain scale
3 months
Study Arms (2)
Pleur-X
EXPERIMENTALPlacement of a permanent drainage under local anesthesia
pleurodesis
EXPERIMENTALPleurodesis with talc in VATS
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years, \<80 years
- First diagnosis of malignant pleural effusion
- Indication to treat the malignant pleural effusion with surgery
- Informed informed consent
You may not qualify if:
- Previous surgeries on the same hemitorace
- Pregnant women
- Trapped lung syndrome
- Patients with estimated life expectancy \< 4-8 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rolf Inderbitzilead
- Clinical Trial Unit Ente Ospedaliero Cantonalecollaborator
Study Sites (1)
Ospedale San Giovanni
Bellinzona, 6500, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rolf Inderbitzi, MD
Ente Ospedaliero Cantonale, Bellinzona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of thoracic surgery department
Study Record Dates
First Submitted
April 6, 2018
First Posted
May 8, 2018
Study Start
January 25, 2018
Primary Completion
March 31, 2020
Study Completion
December 31, 2020
Last Updated
May 8, 2018
Record last verified: 2018-04