Clinical trial NCT00789087: Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Official title: Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Malignant Pleural Effusion.
Keywords: Pleural Effusion.
Talc.
Pleurodesis.
Quality of Life.
Thoracoscopy.
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Malignant pleural effusion confirmed by cytological analysis of pleural fluid and/or pleural biopsy;
* Recurrent pleural effusion with symptoms;
* Chest radiography with lung expansion after thoracocentesis;
* Karnofsky Performance Status \> 70;
* Written informed patient consent were obtained.

Exclusion Criteria:

* Hemorrhagic diathesis;
* Active infection;
* Cutaneous infiltration;
* Patients unable to understand the questionnaires;
* Age: \> 90 yo or \< 18 yo.

Primary outcomes:
measure: Radiological lung expansion after talc pleurodesis and clinical outcome
timeFrame: 6 months
Secondary outcomes:
measure: Clinical efficacy, safety, quality of life and survival.
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo Medical School
Study officials:
affiliation: University of Sao Paulo
name: Ricardo M. Terra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terra RM, Junqueira JJM, Teixeira LR, Vargas FS, Pego-Fernandes PM, Jatene FB. Is full postpleurodesis lung expansion a determinant of a successful outcome after talc pleurodesis? Chest. 2009 Aug;136(2):361-368. doi: 10.1378/chest.08-2448. Epub 2009 Apr 6.