Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 257
- Locations
- 1
- Primary Endpoint
- Time to Pleurodesis (TTP)
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
Arm 1 - Daily
Intrapleural Catheters (IPC) drained every day
Intervention: Intrapleural catheter (IPC) drained (Procedure)
Arm 1 - Daily
Intrapleural Catheters (IPC) drained every day
Intervention: IPC Placement (Procedure)
Arm 1 - Daily
Intrapleural Catheters (IPC) drained every day
Intervention: Chest X-Ray (Radiation)
Arm 2 - 3 Times a Week
IPC drained 3 times a week
Intervention: Intrapleural catheter (IPC) drained (Procedure)
Arm 2 - 3 Times a Week
IPC drained 3 times a week
Intervention: IPC Placement (Procedure)
Arm 2 - 3 Times a Week
IPC drained 3 times a week
Intervention: Chest X-Ray (Radiation)
Outcomes
Primary Outcomes
Time to Pleurodesis (TTP)
Time Frame: 2 weeks after intrapleural catheter placement
Time to pleurodesis (TTP), defined as the time from catheter insertion to catheter removal.
Secondary Outcomes
No secondary outcomes reported