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Trial record 2 of 72 for:    Talc

Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00789087
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : November 11, 2008
Sponsor:
Information provided by:
University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE November 10, 2008
First Posted Date  ICMJE November 11, 2008
Last Update Posted Date November 11, 2008
Study Start Date  ICMJE January 2005
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2008)
Radiological lung expansion after talc pleurodesis and clinical outcome [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2008)
Clinical efficacy, safety, quality of life and survival. [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Official Title  ICMJE Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Malignant Pleural Effusion.
Intervention  ICMJE
  • Procedure: Videothoracoscopic talc poudrage (VT).
    Videothoracoscopic talc poudrage
    Other Name: Videothoracoscopic talc poudrage
  • Procedure: Talc slurry through a chest tube (DT).
    Talc slurry through a chest tube
    Other Name: Talc slurry through a chest tube
Study Arms  ICMJE
  • Active Comparator: 1. Videothoracoscopic talc poudrage (VT)
    Intervention: Procedure: Videothoracoscopic talc poudrage (VT).
  • Active Comparator: 2. Talc slurry through a chest tube (DT)
    Intervention: Procedure: Talc slurry through a chest tube (DT).
Publications * Terra RM, Junqueira JJM, Teixeira LR, Vargas FS, Pêgo-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2008)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00789087
Other Study ID Numbers  ICMJE 1105/04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ricardo M. Terra, University of São Paulo Medical School
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ricardo M. Terra, MD University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP