A Randomized Controlled Trial to Evaluate the Efficacy of Intra-pericardial Instillation of a Sclerosing Agent After Pericardial Drainage in Patients With Malignant Pericardial Effusion Associated With Lung Cancer (JCOG9811)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 31
- 主要终点
- Survival without pericardial effusion at 2 months
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.
详细描述
Malignant pericardial effusions (MPEs), which are commonly associated with cardiac tamponade, make oncologic emergencies requiring prompt drainage. In lung cancer patients, MPE is one of the most unpleasant terminal events. Drainage usually results in prompt palliation of symptoms, but recurrent effusions often occur. Sclerosis with pericardial instillation of various agents is reported to prevent the recurrence, and bleomycin is the most commonly used drug, with fewer toxicities compared with others. There is, however, no prospective trial of pericardial sclerosis as compared with drainage alone for MPEs, and it is far from clear whether sclerosis really benefits these patients in terminal stages.
Comparison: Intra-pericardial instillation of bleomycin after pericardial drainage versus drainage alone for MPEs caused by lung cancer.
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
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically documented lung cancer
- •Clinically stable condition after pericardial drainage for malignant pericardial effusion (not necessary that it be documented by cytology)
- •Expected to live 6 weeks or longer
- •Sufficient organ function
- •Signed informed consent
排除标准
- •Myocardial infarction or unstable angina within 3 months
- •Constrictive pericarditis
- •Active pneumonitis
- •Severe infection or disseminated intravascular coagulation (DIC)
- •Other severe co-morbidity which could not be relieved with pericardial drainage
- •Chemotherapy-naive small cell lung cancer
研究组 & 干预措施
1
Procedure/Surgery: Observation alone after pericardial drainage
干预措施: Observation alone after pericardial drainage (Procedure)
2
Drug: Pericardial instillation of bleomycin after drainage
干预措施: Pericardial instillation of bleomycin after drainage (Drug)
结局指标
主要结局
Survival without pericardial effusion at 2 months
次要结局
- long-term (> 6 months) effect on cardiac function
- Successful extubation of pericardial drainage tube
- time to extubation
- survival without pericardial effusion at 1, 2, 4, 6, 12 months
- symptom palliation
- complication