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Talc Pleurodesis in Patients With Recurrent Malignant Pleural Effusion

NCT ID: NCT00789087

Last Updated: 2008-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Recurrent Malignant Pleural Effusion.

Keywords

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Pleural Effusion. Talc. Pleurodesis. Quality of Life. Thoracoscopy.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1. Videothoracoscopic talc poudrage (VT)

Group Type ACTIVE_COMPARATOR

Videothoracoscopic talc poudrage (VT).

Intervention Type PROCEDURE

Videothoracoscopic talc poudrage

2. Talc slurry through a chest tube (DT)

Group Type ACTIVE_COMPARATOR

Talc slurry through a chest tube (DT).

Intervention Type PROCEDURE

Talc slurry through a chest tube

Interventions

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Videothoracoscopic talc poudrage (VT).

Videothoracoscopic talc poudrage

Intervention Type PROCEDURE

Talc slurry through a chest tube (DT).

Talc slurry through a chest tube

Intervention Type PROCEDURE

Other Intervention Names

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Videothoracoscopic talc poudrage Talc slurry through a chest tube

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of São Paulo Medical School

Principal Investigators

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Ricardo M. Terra, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of São Paulo Medical School

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 19349389 (View on PubMed)

Other Identifiers

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1105/04

Identifier Type: -

Identifier Source: org_study_id