Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00789087
First received: November 10, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Recurrent Malignant Pleural Effusion.
Procedure: Videothoracoscopic talc poudrage (VT).
Procedure: Talc slurry through a chest tube (DT).
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Radiological lung expansion after talc pleurodesis and clinical outcome [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical efficacy, safety, quality of life and survival. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: January 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Videothoracoscopic talc poudrage (VT) Procedure: Videothoracoscopic talc poudrage (VT).
Videothoracoscopic talc poudrage
Other Name: Videothoracoscopic talc poudrage
Active Comparator: 2. Talc slurry through a chest tube (DT) Procedure: Talc slurry through a chest tube (DT).
Talc slurry through a chest tube
Other Name: Talc slurry through a chest tube

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789087

Locations
Brazil
University of São Paulo Medical School
São Paulo, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Ricardo M. Terra, MD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Ricardo M. Terra, University of São Paulo Medical School
ClinicalTrials.gov Identifier: NCT00789087     History of Changes
Other Study ID Numbers: 1105/04
Study First Received: November 10, 2008
Last Updated: November 10, 2008
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Pleural Effusion.
Talc.
Pleurodesis.
Quality of Life.
Thoracoscopy.

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on April 14, 2014