Trial record 3 of 68 for:    Open Studies | "Pleural Effusion"

Relationship Between Pleural Elastance and Effectiveness of Pleurodesis on Recurrent Malignant Pleural Effusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Grupo de Pesquisa em Pleura e Oncologia Toracica
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Grupo de Pesquisa em Pleura e Oncologia Toracica
ClinicalTrials.gov Identifier:
NCT01819363
First received: June 1, 2012
Last updated: March 24, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Pleural Effusion, Malignant
Procedure: Pleural elastance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Pleural Elastance and Effectiveness of Pleurodesis on Recurrent Malignant Pleural Effusion

Further study details as provided by Grupo de Pesquisa em Pleura e Oncologia Toracica:

Primary Outcome Measures:
  • Radiological Effective [ Time Frame: 1 month after the inclusion ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Clinical Effectiveness [ Time Frame: 1 months after inclusion; each 3 months after inclusion until death ] [ Designated as safety issue: No ]
    The clinical effectiveness will be considered a binary variable (success or failure). We will consider failure of pleurodesis when, at any time of follow-up procedure was necessary some new procedure for emptying pleural effusion, is puncture, drainage or thoracoscopy. Such procedures shall be appointed by the surgical team of the Pleural Diseases Clinic of the HCFMUSP considering clinical criteria (symptoms: dyspnea, cough and chest pain) and radiological (new fluid accumulation in chest tomography).

  • Analysis of Quality of Life [ Time Frame: at inclusion, 1 month after inclusion, each 3 months after inclusion until death ] [ Designated as safety issue: No ]
    To analyze the quality of life we use the WHOQoL-Bref. The WHOQOL-Bref is a reduced version of the questionnaire of quality of life developed by the World Health Organization multi-cultural context, aiming to cover as many countries and cultures as possible and thus can be used internationally, allowing the comparison between the results obtained in different locations.

  • Analysis of Pain [ Time Frame: at inclusion, 1 month after inclusion; each 3 months after inclusion until death ] [ Designated as safety issue: No ]
    Pain assessment will be made by patient´s quantifying of the Visual Analog Scale of Pain. The questionnaire will be applied by the same investigator during the initial evaluation, the returns one month after the procedure and then quarterly.

  • Analysis of dyspnea [ Time Frame: at inclusion, 1 month after inclusion; each 3 months after inclusion until death ] [ Designated as safety issue: No ]
    The analysis of dyspnea will be made by quantifying the functionality with the dyspnea scale of the British Medical Research Council (MRC). The questionnaire will be applied by the same investigator during the initial evaluation, the returns one month after the procedure and then quarterly.

  • Security Analysis [ Time Frame: at inclusion, 1 month after inclusion, each 3 months after inclusion until death ] [ Designated as safety issue: Yes ]
    For the analysis of safety procedures shall be deemed times of hospitalization and drainage and occurrence of complications. Such data will be obtained during the inpatient and outpatient follow-up as previously described. Other complications will be recorded as the occurrence and graded according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE).


Estimated Enrollment: 140
Study Start Date: February 2012
Estimated Study Completion Date: January 2016
Groups/Cohorts Assigned Interventions
Study group
Patients with Malignant pleural effusion according to inclusion and exclusion criteria.
Procedure: Pleural elastance
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819363

Contacts
Contact: Pedro HX Araújo, MD 55-11-8316-4791 phnabuco@terra.com.br
Contact: Ricardo M Terra, MD, PhD 55-11-9975-1178 rmterra@uol.com.br

Locations
Brazil
INCOR - Heart Institute Recruiting
São Paulo, SP, Brazil, 05403-000
Contact: Pedro HX Araújo, MD    55-11-8316-4791    phnabuco@terra.com.br   
Contact: Ricardo M Terra, MD, PhD    55-11-9975-1178    rmterra@uol.com.br   
Principal Investigator: Pedro HX Araújo, MD         
Principal Investigator: Ricardo M Terra, MD, PhD         
Sub-Investigator: Victor Ishii, student         
Sub-Investigator: Rodrigo C Chate, MD         
Sub-Investigator: Paulo M Pêgo-Fernandes, MD, PhD         
Sub-Investigator: Francisco S Vargas, MD, PhD         
Sub-Investigator: Fabio B Jatene, MD, PhD         
Sponsors and Collaborators
Grupo de Pesquisa em Pleura e Oncologia Toracica
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Ricardo M Terra, MD, PhD Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  More Information

No publications provided

Responsible Party: Grupo de Pesquisa em Pleura e Oncologia Toracica
ClinicalTrials.gov Identifier: NCT01819363     History of Changes
Other Study ID Numbers: GPPOT-01
Study First Received: June 1, 2012
Last Updated: March 24, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Grupo de Pesquisa em Pleura e Oncologia Toracica:
Pleural effusion
Pleural elastance
Pleurodesis
Quality of life
Computed Tomography

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Neoplasms
Neoplasms by Site
Pleural Diseases
Pleural Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014