A Study to Compare the Efficacy and Safety of Intrapleural Doxycycline Versus Iodopovidone for Performing Pleurodesis in Malignant Pleural Effusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Failed pleurodesis
研究概览
简要总结
Malignant pleural effusion (MPE) arises in advanced-stages of malignancies and frequently heralds a poor prognosis.If the underlying malignancy is chemo sensitive (e.g., small-cell carcinoma of lung & lymphoma), systemic chemotherapy may control the pleural effusion. Instilling of sclerosing agents into the pleural cavity (pleurodesis) is a common method for the management of MPE. According to a recent survey, tetracycline or its derivative (doxycycline) is the preferred agent for performing pleurodesis at many centers. In a previous study from the investigators' center, the investigators have demonstrated equal efficacy of iodopovidone in comparison to talc in inducing pleural symphysis. Also, iodopovidone has been postulated to have anti-neoplastic effects and hence may help in reducing the drain output. Apart from these benefits iodopovidone is easily available and is cost effective. The investigators believe that iodopovidone will have better efficacy than doxycycline in inducing pleurodesis in malignant pleural effusion.
详细描述
Introduction & Review of literature Malignant pleural effusion (MPE) arises in advanced-stages of malignancies and frequently heralds a poor prognosis. Most patients with MPE are symptomatic. The most common symptom is exertional dyspnea. Most patients undergo chemotherapy or local treatments to palliate symptoms such as dyspnea, cough & chest pain, to improve quality of life. If the underlying malignancy is chemo sensitive (e.g., small-cell carcinoma of lung & lymphoma), systemic chemotherapy may control the pleural effusion.1 However, when pleural effusion persists or reaccumulates after chemotherapy, the management of refractory MPE includes local therapeutic methods such as thoracentesis, pleurodesis, pleurectomy, or pleuroperitoneal shunting. Instilling of sclerosing agents into the pleural cavity (pleurodesis) is a common method for the management of MPE. For several years, various agents such as anti-neoplastics (e.g., nitrogen mustard, bleomycin), tetracycline derivatives, talc, erythromycin, silver nitrate, and povidone-iodine have been injected into the pleural cavity to create pleurodesis.
According to a recent survey, tetracycline or its derivative (doxycycline) is the preferred agent for performing pleurodesis at many centers.7 However, intravenous preparation of doxycycline is not freely available and also induces severe inflammation in the pleura that results in severe chest pain and discomfort to the patient. In a previous study from the investigators' center, the investigators have demonstrated equal efficacy of iodopovidine in comparison to talc in inducing pleural symphysis.8 Also, iodopovidine has been postulated to have anti-neoplastic effects and hence may help in reducing the drain output. Apart from these benefits iodopovidine is easily available and is cost effective. The investigators believe that iodopovidone will have better efficacy than doxycycline in inducing pleurodesis in malignant pleural effusion.
Study hypothesis In patients with malignant pleural effusion, pleurodesis with intrapleural instillation of iodopovidone will have better efficacy in comparison with doxycycline.
Methods
Study design: This will be a randomized double blind study conducted in the Department of Pulmonary Medicine, PGIMER, Chandigarh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •recurrent symptomatic malignant pleural effusion, with subjective improvement of dyspnea following thoracentesis
排除标准
- •history of any allergy to iodine or doxycycline
- •history of thyroid disorders
- •failure of lung expansion after insertion of intercostal tube (trapped lung)
- •presence of air leaks
- •advanced malignancy with limited predicted life expectancy (<30 days)
- •failure to provide informed consent
结局指标
主要结局
Failed pleurodesis
时间窗: 30 days
reaccumulation of pleural fluid requiring therapeutic thoracentesis, persistence of drainage output \>250mL/day requiring repeat procedure, lack of success requiring surgical intervention
Complete success
时间窗: 30 days
long-term relief of symptoms related to the effusion, with absence of re-accumulation of fluid on chest radiograph at 30 days
Partial success
时间窗: 30 days
diminution of dyspnea related to the effusion, with only partial reaccumulation of fluid and no requirement for therapeutic thoracentesis
次要结局
- Time to pleurodesis(1 week)
研究者
Ritesh Agarwal
Additional Professor
Post Graduate Institute of Medical Education and Research, Chandigarh