Evaluation of Chest Pain, Effectiveness and Safety of Pleurodesis With Pleural Catheters and Silver Nitrate for Malignant Pleural Effusion.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Chest pain on the first five days after pleurodesis
研究概览
简要总结
The primary purpose of this study is to determinate the degree of chest pain on patients with malignant pleural effusion submitted to pleurodesis with silver nitrate in three different dosages and concentrations ( 30ml 0.5% ; 30ml 0.3% ; 60ml 0.3%). Our secondary purpose is to evaluate the efficacy and occurence of adverse effects in the usage of silver nitrate for pleurodesis in the aforementioned dosages/concentrations.
详细描述
Malignant pleural effusion is a frequent complication in advanced neoplasia. Pleurodesis is the procedure of choice for symptomatic control, with talc as the sclerosing agent of choice. However, the occurrence of severe adverse effects associated with its use has led to the search for other agents.
Silver nitrate poses an option, presenting excellent results in animal models and having successful usage in pleurodesis in the past. Although important, the current literature on the effective use of silver nitrate for pleurodesis is still too scarce, and a deeper knowledge on the occurrence of adverse side effects, especially pain, is still necessary to allow the substance to be considered as an effective alternative to talc, as well as for the definition of an adequate dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant pleural effusion confirmed by cytologic analysis of the fluid and/or pleural biopsy.
- •Recurrent and symptomatic malignant pleural effusion.
- •Full pulmonary expansion (>90%) post thoracocentesis, confirmed via chest x-ray.
- •Karnofsky Performance Status >30
- •Agreement to participate of the study by signing of the Informed Consent Term.
排除标准
- •Coagulopathies (prothrombin activity <50%) and/or thrombocytopenia (<80000 count).
- •Active pleural or systemic infection.
- •Massive skin neoplastic infiltration.
- •Inability of understanding the pain scale.
- •Previous pleural procedures (except for thoracocentesis and/or pleural biopsy).
- •Refusal to participate of the study.
研究组 & 干预措施
Silver Nitrate 1
Patients submitted to pleurodesis via pleural catheter using 30ml of 0.5% silver nitrate solution.
干预措施: Silver Nitrate (Drug)
Silver Nitrate 2
Patients submitted to instilation of 30ml 0.3% silver nitrate solution via pleural catheter.
干预措施: Silver Nitrate (Drug)
Silver Nitrate 3
Patients submitted to instilation of 60ml 0.3% silver nitrate solution via pleural catheter.
干预措施: Silver Nitrate (Drug)
结局指标
主要结局
Chest pain on the first five days after pleurodesis
时间窗: Along the first five days after treatment
Chest pain will be evaluated via Visual Analog Scale.
Chest pain after 10 days of pleurodesis
时间窗: On the 10th day after the procedure.
Chest pain will be assessed using the Visual Analog Scale
Chest pain after 30 days of pleurodesis
时间窗: Within 30 days of the procedure
Chest pain will be evaluated by Visual Analog Scale
次要结局
- Effectiveness of the pleurodesis(After 30 days of the procedure)
- Dyspnea(Before the procedure, during the first five days after the procedure, ten days after the procedure and on the 30th day post-procedure.)
- Adverse effects(Within the first 5 days after the procedure, on the 10th day after the procedure and on the 30th day after the procedure)