NCT01819363

Brief Summary

The objective of this study is to analyze the correlation between pleural elastance and the radiological effectiveness (measured by chest tomography) of pleurodesis performed via catheters in patients with RMPE. The secondary objectives of this study are: correlate pleural elastance with quality of life, analysis of dyspnea and pain after the procedure, clinical effectiveness, complications and mortality in 30 days.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 27, 2013

Status Verified

March 1, 2013

First QC Date

June 1, 2012

Last Update Submit

March 24, 2013

Conditions

Pleural Effusion, Malignant

Keywords

Pleural effusionPleural elastancePleurodesisQuality of lifeComputed Tomography

Outcome Measures

Primary Outcomes (1)

  • Radiological Effective

    The effectiveness will be measured by radiographic tomography of the chest. Will be measured volumes of pleural fluid in chest CT after placement of the drain and 1 month after pleurodesis

    1 month after the inclusion

Secondary Outcomes (5)

  • Clinical Effectiveness

    1 months after inclusion; each 3 months after inclusion until death

  • Analysis of Quality of Life

    at inclusion, 1 month after inclusion, each 3 months after inclusion until death

  • Analysis of Pain

    at inclusion, 1 month after inclusion; each 3 months after inclusion until death

  • Analysis of dyspnea

    at inclusion, 1 month after inclusion; each 3 months after inclusion until death

  • Security Analysis

    at inclusion, 1 month after inclusion, each 3 months after inclusion until death

Study Arms (1)

Study group

Patients with Malignant pleural effusion according to inclusion and exclusion criteria.

Procedure: Pleural elastance

Interventions

Pleural elastancePROCEDURE

The pleural pressure level will be zero at the time of the insertion site of the drain on the skin. The pleural pressure is set to the value measured at end-expiration. The pleural pressure is measured at baseline, after withdrawal of 10 ml of liquid and thereafter every 400 ml of pleural effusion evacuated to the pressure to be negative, from that moment the measurement will occur every 200 ml of pleural effusion drained to obtain 800 ml of liquid. Patients that are removed less than 800 ml of liquid will be excluded from the protocol. The pleural elastance is then calculated in cm H2O / L and the data placed in a pressure curve by volume.

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with malignant pleural effusion diagnosed by pleural fluid cytology and / or pleural biopsy

You may qualify if:

  • Malignant pleural effusion diagnosed by pleural fluid cytology and / or pleural biopsy;
  • Recurrent pleural effusion (new accumulation of fluid after puncture) and symptoms (dyspnea and / or chest pain);
  • Complete lung expansion (\> 90%) after puncture emptying confirmed by chest radiography;
  • Karnofsky index (KPS - Karnofsky Performance Status) \> 30;
  • Agreed to participate in the study and sign an informed consent.

You may not qualify if:

  • Thrombocytopenia or coagulation disorders (prothrombin activity \<50% and platelet count \<80,000 mm3);
  • Endobronchial obstruction by the neoplasm;
  • Major pulmonary fibrosis or lymphangitis carcinomatosis ipsilateral to the effusion;
  • Volume drained \<800 mL;
  • No contact between the pleural surfaces after draining;
  • Pleural or active systemic infection;
  • Massive neoplastic infiltration of the skin;
  • Inability to understand the quality of life questionnaire;
  • Age less than 18 years;
  • Previous pleural procedures (except punctures and needle biopsies).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INCOR - Heart Institute

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, MalignantPleural Effusion

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural DiseasesRespiratory Tract Diseases

Study Officials

  • Ricardo M Terra, MD, PhD

    Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    STUDY CHAIR

Central Study Contacts

Pedro HX Araújo, MD

CONTACT

55-11-8316-4791phnabuco@terra.com.br

Ricardo M Terra, MD, PhD

CONTACT

55-11-9975-1178rmterra@uol.com.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2012

First Posted

March 27, 2013

Study Start

February 1, 2012

Study Completion

January 1, 2016

Last Updated

March 27, 2013

Record last verified: 2013-03

Locations

BR(1)