Efficacy of pleurodesis using Doxycycline 500mg, Doxycycline 1000mg and 4g Talc slurry in management of Malignant Pleural Effusion – A pilot study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To assess the success rates and complications of high-dose doxycycline 1000mg and talc slurry 4gm in comparison to a standard dose of doxycycline 500mg for pleurodesis in cases of malignant pleural effusion
研究概览
简要总结
Malignant pleural effusion (MPE) is a common complication of advanced malignancy with a poor prognosis.Progressive dyspnea is the most common symptom followed by cough and chest pain that affect the quality of life.Current local managements include thoracentesis, pleurodesis, chest tube drainage, indwelling pleural catheter drainage, pleurectomy, and pleuro peritoneal shunting.Pleurodesis is a procedure aiming at the adhesion of the visceral and parietal pleura that prevents the accumulation of MPE and subsequently improves symptoms. Pleurodesis can be completed by chemical sclerosants or by physical abrasion of pleural surfaces during thoracoscopy or thoracotomy. In this study we are going to compare the efficacy of pleurodesis using 3 different sclerosants - doxycycline 500mg, doxycyline 1000mg and talc slurry 4gm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed malignant pleural effusion cases.
排除标准
- •Previously attempted and failed pleurodesis
- •Contraindications for pleurodesis
- •Contraindication for ICD tube placement
- •History of allergy to any tetracycline derivatives or talc.
- •Previous history of ARDS.
结局指标
主要结局
To assess the success rates and complications of high-dose doxycycline 1000mg and talc slurry 4gm in comparison to a standard dose of doxycycline 500mg for pleurodesis in cases of malignant pleural effusion
时间窗: At the end of one week
次要结局
- To assess status of pleurodesis(at the end of one month)