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


Phase 4
18 Years
90 Years
Not Enrolling
Both
Recurrent Malignant Pleural Effusion.

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Radiological lung expansion after talc pleurodesis and clinical outcome

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Ricardo M. Terra, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Sao Paulo

Authority:

Brazil: Ethics Committee

Study ID:

1105/04

NCT ID:

NCT00789087

Start Date:

January 2005

Completion Date:

January 2008

Related Keywords:

  • Recurrent Malignant Pleural Effusion.
  • Pleural Effusion.
  • Talc.
  • Pleurodesis.
  • Quality of Life.
  • Thoracoscopy.
  • Pleural Effusion
  • Pleural Effusion, Malignant

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