Indwelling Pleural Catheter for Trapped Lung
1 other identifier
interventional
20
1 country
1
Brief Summary
Malignant pleural effusion (MPE) is a complication of almost any site of primary cancer as well as primary tumors of the pleura. Half of MPE patients have non-expendable trapped lungs not suitable for talc pleurodesis. Indwelling pleural catheters (IPCs), however, can be used in this cohort of patients, bringing about an improvement in dyspnea and quality of life (QOL). The aim of this study is to obtain pilot data - comparing patients receiving two different types of indwelling pleural catethers normally used in clinical practice (10 patients receiving Pleurocath® and 10 patients receiving PleurX®) - for power calculation of a Randomized Controlled Trial comparing two different drainages for MPE trapped lung.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Shorter than P25 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
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2018
CompletedFirst Submitted
Initial submission to the registry
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedNovember 26, 2024
June 1, 2018
7 months
March 21, 2018
November 22, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Visual Analog Scale (VAS) range 0 (no pain) - 100 (maximum pain)
Thoracic pain
Post operative day 4th
Visual Analog Scale (VAS) range 0 (no dyspnea) - 100 (maximim dyspnea)
Dyspnea
Post operative day 4th
Study Arms (2)
PleurX
EXPERIMENTALPositioning of Pleurx drainage during surgical exploration if lung does not reinflate
Pleurocath
EXPERIMENTALPositioning of Pleur o cath drainage during surgical exploration if lung does not reinflate
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients, with a clinical confident diagnosis of symptomatic malignant pleural effusion, enrolled for VATS exploration but not amenable of VATS talc poudrage because of trapped lung (patients with only partial expansion however receiving talc poudrage, but needing permanent pleural cathetes, are also eligible)
You may not qualify if:
- \- Age younger than 18 years
- Expected survival of less than 3 months
- Chylothorax
- Total white blood cell count less than 1000/microL
- Pregnancy or lactating mothers
- Irreversible bleeding diathesis
- Irreversible visual impairment
- Contraindications to general anesthesia
- Poor general clinical conditions ( ECOG PS \>=2)
- Patients unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European Institute of Oncology
Milan, 20141, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Petrella, MD, PhD
European Institute of Oncology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2018
First Posted
June 8, 2018
Study Start
April 21, 2017
Primary Completion
November 3, 2017
Study Completion
February 15, 2018
Last Updated
November 26, 2024
Record last verified: 2018-06