Study Protocol for Pressurized IntraThoracic Aerosol Chemotherapy in Malignant Pleural Effusion
Author Information
Author(s): Pernille Schjødt Hansen, Martin Graversen, Sönke Detlefsen, Alan Patrick Ainsworth, Claus Wilki Fristrup, Lise Eckhoff, Mia Jelin-Klaric, Michael Bau Mortensen
Primary Institution: Odense University Hospital, Odense, Denmark
Hypothesis
Is Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) feasible and safe for patients with malignant pleural effusion?
Conclusion
PITAC is expected to be safe and feasible for patients and personnel, potentially reducing malignant pleural effusion volume.
Supporting Evidence
- PITAC has been shown to be safe and feasible in previous studies.
- Current treatments for malignant pleural effusion are suboptimal and often require repeated interventions.
- Patients with malignant pleural effusion have a poor quality of life and limited life expectancy.
Takeaway
This study is testing a new way to treat fluid buildup in the lungs caused by cancer, hoping it will be safe and help patients feel better.
Methodology
A phase-I, non-randomized, prospective study where 20 patients with malignant pleural effusion will receive two or more PITAC treatments at four-week intervals.
Potential Biases
Potential bias may arise from the non-randomized design and the single-center nature of the study.
Limitations
The study is limited by the small sample size and the lack of prior data to support the estimated number of patients needed.
Participant Demographics
Patients with symptomatic malignant pleural effusion, aged 18 and older, with a life expectancy of at least 3 months.
Digital Object Identifier (DOI)
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