Recurrent Malignant Pleural Effusion. Clinical Trial
Official title:
Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
The purpose of this study is to analyze and compare radiological lung expansion after talc pleurodesis performed either by videothoracoscopy or chest tube and correlate it with clinical outcome. Secondary endpoints evaluated were: clinical efficacy, safety, quality of life and survival.
Talc pleurodesis is the most popular method to control symptoms of recurrent malignant
pleural effusion. The intrapleural talc delivery may be by videothoracoscopy and talc
poudrage or talc slurry thought a chest tube and the best method is still controversial.
Although the lung expansion is a key criteria for success of the procedure, its
characteristics are poorly studied.
Patients were enrolled into two groups: videothoracoscopic talc poudrage (VT) and talc
slurry through a chest tube (DT). Lung expansion was evaluated through chest CT scans
obtained obtained in the first 7 days and 1, 3 and 6 months after pleurodesis. All
examinations were revised by two independent observers. Clinical efficacy (considered as
lack of new procedures during follow up), complications, drainage duration, hospital stay
and quality of life (general and specific questionnaires) were also analyzed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment