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Completed

NCT Number: NCT00789087

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.

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Key information

Conditions

Recurrent Malignant Pleural Effusion. Neoplasms Neoplasms by Site Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of São Paulo Medical School

São Paulo, 01246903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Videothoracoscopic talc poudrage (VT).

Procedure

Videothoracoscopic talc poudrage

Other names: Videothoracoscopic talc poudrage

Talc slurry through a chest tube (DT).

Procedure

Talc slurry through a chest tube

Other names: Talc slurry through a chest tube

Primary outcomes

  1. Radiological lung expansion after talc pleurodesis and clinical outcome

    Time frame: 6 months

Secondary outcomes

  1. Clinical efficacy, safety, quality of life and survival.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 11, 2008
Registry last updated
Nov 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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