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Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00789087
Enrollment
60
Registered
2008-11-11
Start date
2005-01-31
Completion date
2008-01-31
Last updated
2008-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Malignant Pleural Effusion.

Keywords

Pleural Effusion., Talc., Pleurodesis., Quality of Life., Thoracoscopy.

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.

Interventions

PROCEDUREVideothoracoscopic talc poudrage (VT).

Videothoracoscopic talc poudrage

PROCEDURETalc slurry through a chest tube (DT).

Talc slurry through a chest tube

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Radiological lung expansion after talc pleurodesis and clinical outcome6 months

Secondary

MeasureTime frame
Clinical efficacy, safety, quality of life and survival.6 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026