Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- Time to Pleurodesis (TTP)
研究概览
简要总结
The goal of this clinical research study is to learn if draining the IPC every day is better at than draining it 3 times a week.
详细描述
An IPC is a silicone (rubberlike) tube that is inserted into the chest cavity to drain excess fluid that is in your chest. At MD Anderson, patients are told to drain their IPC every day. At other institutions, patients are told to drain their IPC less often.
Before IPC Placement:
Before you can have the IPC inserted, the following tests and procedures will be performed to help the doctor decide if you need to have an IPC inserted:
- You will perform a 6 minute walk test to learn your check your breathing ability and fatigue level. To perform the walk test, you will be asked to walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time if necessary.
- After signing this consent, you will fill out 2 questionnaires asking questions about how you feel and any symptoms you may have. These questionnaires will take about 20-30 minutes to complete.
IPC placement:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic pleural effusion requiring placement of an IPC.
- •Signed informed consent prior to any study related procedures.
- •Subject must be age 18 years or over.
排除标准
- •Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks incompletely healed surgical incision before randomization.
- •Evidence of empyema or history of empyema of the affected hemithorax
- •Non-correctable bleeding diathesis
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Principal Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- •Participation in any clinical trial that prevents randomization of the subject to either strategy.
- •Clinical evidence of skin infection at the potential site of IPC placement.
- •Current or prior IPC placement, or any intervention to manage recurrent malignant pleural effusion on the contralateral hemithorax (excluding thoracentesis).
研究组 & 干预措施
Arm 1 - Daily
Intrapleural Catheters (IPC) drained every day
干预措施: Intrapleural catheter (IPC) drained (Procedure)
Arm 1 - Daily
Intrapleural Catheters (IPC) drained every day
干预措施: IPC Placement (Procedure)
Arm 1 - Daily
Intrapleural Catheters (IPC) drained every day
干预措施: Chest X-Ray (Radiation)
Arm 2 - 3 Times a Week
IPC drained 3 times a week
干预措施: Intrapleural catheter (IPC) drained (Procedure)
Arm 2 - 3 Times a Week
IPC drained 3 times a week
干预措施: IPC Placement (Procedure)
Arm 2 - 3 Times a Week
IPC drained 3 times a week
干预措施: Chest X-Ray (Radiation)
结局指标
主要结局
Time to Pleurodesis (TTP)
时间窗: 2 weeks after intrapleural catheter placement
Time to pleurodesis (TTP), defined as the time from catheter insertion to catheter removal.
次要结局
未报告次要终点