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临床试验/NCT01819363
NCT01819363Unknown不适用

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

Grupo de Pesquisa em Pleura e Oncologia Toracica1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
140
试验地点
1
主要终点
Radiological Effective

研究概览

简要总结

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.

详细描述

  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 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.

A chest radiograph is performed and the patient will be eligible for pleurodesis if there is a lung expansion that will allow some contact between the pleural surfaces, even partially.

The eligible patients for pleurodesis will be referred to an outpatient procedure room or remain in their ward beds, where, under sterile conditions will be submitted to the instillation of silver nitrate or talc mineral. Analgesia is given only when necessary. The drain is kept closed for one hour, after this period, the drain is opened and the patient discharged and instructed to return within 1 week in outpatient cases. A CT of the chest will be held in the near-pleurodesis, while the patient is still on the drain and with a maximum of five days after pleurodesis. In the outpatient possible complications are evaluated. The drain is removed when less than 100 ml/day of pleural fluid is drained.

After removal of the drain will be scheduled one month in return for clinical evaluation and another CT scan of the chest. Since then the returns will be quarterly. In all returns will be evaluated further chest radiographs, questionnaires of quality of life, dyspnea and pain shall be applied and will be actively investigated the occurrence of complications. Patients who fail to attend the consultation will be contacted by phone. Non-scheduled queries occur in case of clinical necessity (relapses, complications, etc.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Radiological Effective

时间窗: 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

次要结局

  • 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)

研究者

发起方
Grupo de Pesquisa em Pleura e Oncologia Toracica
申办方类型
Network
责任方
Sponsor

研究点 (1)

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