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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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

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.

Detailed Summary:

  1. PURPOSE 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.

  2. METHODS Patients who participate in this study will be selected at the Pleural Diseases Clinic of Department of Thoracic Surgery and Department of Pulmonology of the Medical School of USP. Shall be deemed elected patients with: 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); parcial lung expansion (> 50%) after puncture emptying confirmed by chest radiography; Karnofsky index (KPS - Karnofsky Performance Status) > 30; and agreed to participate in the study and sign an informed consent.

    The investigators will include 140 patients in the study, predicting loss of some patients.

  3. PROCEDURE After insertion of the tube, this will be fixed to the skin with nonabsorbable sutures and wound covered with a bandage. The catheter is connected to a three-way stopcock. On its output side is connected to a delivery unit for measuring central venous pressure or a gear connected to an electronic transducer of vascular pressure. In the output is connected to the distal extension tube with the proximal end of the valve and the distal end of Heimlich is connected to a collection bag. The pleural pressure level will be zero at the time of the inserti
    Sponsor: Grupo de Pesquisa em Pleura e Oncologia Toracica

    Current Primary Outcome: Radiological Effective [ Time Frame: 1 month after the inclusion ]

    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


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Clinical Effectiveness [ Time Frame: 1 months after inclusion; each 3 months after inclusion until death ]
      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 ]
      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 ]
      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 ]
      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 ]
      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).


    Original Secondary Outcome: Same as current

    Information By: Grupo de Pesquisa em Pleura e Oncologia Toracica

    Dates:
    Date Received: June 1, 2012
    Date Started: February 2012
    Date Completion: January 2016
    Last Updated: March 24, 2013
    Last Verified: March 2013