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Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

Primary Purpose

Recurrent Malignant Pleural Effusion.

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Videothoracoscopic talc poudrage (VT).
Talc slurry through a chest tube (DT).
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Malignant Pleural Effusion. focused on measuring Pleural Effusion., Talc., Pleurodesis., Quality of Life., Thoracoscopy.

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of São Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1. Videothoracoscopic talc poudrage (VT)

2. Talc slurry through a chest tube (DT)

Arm Description

Outcomes

Primary Outcome Measures

Radiological lung expansion after talc pleurodesis and clinical outcome

Secondary Outcome Measures

Clinical efficacy, safety, quality of life and survival.

Full Information

First Posted
November 10, 2008
Last Updated
November 10, 2008
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00789087
Brief Title
Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Official Title
Analysis of Clinical and Radiological Results of Two Methods of Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Malignant Pleural Effusion.
Keywords
Pleural Effusion., Talc., Pleurodesis., Quality of Life., Thoracoscopy.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Videothoracoscopic talc poudrage (VT)
Arm Type
Active Comparator
Arm Title
2. Talc slurry through a chest tube (DT)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Videothoracoscopic talc poudrage (VT).
Other Intervention Name(s)
Videothoracoscopic talc poudrage
Intervention Description
Videothoracoscopic talc poudrage
Intervention Type
Procedure
Intervention Name(s)
Talc slurry through a chest tube (DT).
Other Intervention Name(s)
Talc slurry through a chest tube
Intervention Description
Talc slurry through a chest tube
Primary Outcome Measure Information:
Title
Radiological lung expansion after talc pleurodesis and clinical outcome
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical efficacy, safety, quality of life and survival.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo M. Terra, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo Medical School
City
São Paulo
ZIP/Postal Code
01246903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19349389
Citation
Terra RM, Junqueira JJM, Teixeira LR, Vargas FS, Pego-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.
Results Reference
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Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

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