Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies
18 Years
N/A
Both
Advanced Cancer, Pleural Effusion
Trial Information
Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies
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:
You will have an IPC placed to drain the fluid in your chest cavity. You will be given a
separate consent for to sign for this procedure and your doctor will give you detailed
instructions regarding the procedure itself.
Study Groups:
A chest x-ray will be performed right after the IPC placement. You will be randomly
assigned (as in the flip of a coin) to 1 of 2 groups, after your chest x-ray or the
following day when you return to clinic for follow up. Group 1 will have their IPC drained
every day, and Group 2 will have their IPC drained 3 times a week (Monday, Wednesday, and
Friday or Tuesday, Thursday, and Saturday). You will be given detailed instructions on when
and how to drain your catheter.
Follow-Up Visits:
Two (2) weeks after you receive the IPC, you will return to the clinic for a follow-up visit
so the doctor can check your IPC for possible leaking, infection, and see how much pleural
fluid has drained. After the follow-up visit at 2 weeks, you will come into the clinic
every 4 weeks until your IPC is removed. During each follow-up visit the following tests
and procedures will be performed to see how your condition has changed:
- You will have a chest x-ray to see if the amount of pleural fluid has decreased and to
see if your lung has re-expanded.
- You will perform the 6 minute walk test.
- You will complete the same 2 questionnaires.
- The IPC will be drained.
After the IPC is removed, at 3 and 6 months, you will have follow-up visits at M. D.
Anderson or at your local doctor's office. At these visits you will have chest x-rays to
see if the pleural fluid has come back or not.
The study personnel will contact you by phone, email or mail periodically during the study
and at 3 months and 6 months after the IPC has been removed to check on your status. The
phone calls, email, or mail follow-up will take about 5-10 minutes to complete. You will be
asked how you are doing and if you have any questions or concerns that you may want to
discuss with the your doctor. You will also be asked if you have had a chest x-ray since
being off study. If you have had an x-ray, you will be asked to share the results with the
study doctor.
This is an investigational study. All of the study related tests and procedures are
considered standard of care.
Up to 250 patients will take part in this study. All will be enrolled at MD Anderson.
Inclusion Criteria:
1. Patients with symptomatic pleural effusion requiring placement of an IPC.
2. Signed informed consent prior to any study related procedures.
3. Subject must be age 18 years or over.
Exclusion Criteria:
1. 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.
2. Evidence of empyema or history of empyema of the affected hemithorax
3. Non-correctable bleeding diathesis
4. Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule.
5. 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.
6. Participation in any clinical trial that prevents randomization of the subject to
either strategy.
7. Clinical evidence of skin infection at the potential site of IPC placement.
8. Current or prior IPC placement on the contralateral hemithorax.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Patients with Pleurodesis (Pd)
Outcome Description:
Cochran-Mantel Haenszel (1952, 1959) chi-square test used to compare 2 study arms with respect to Pd rate in order to test if draining intrapleural catheter (IPC) every day is better than draining it 3 times a week.
Outcome Time Frame:
3 Years
Safety Issue:
No
Principal Investigator
Carlos A. Jimenez, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2007-0808
NCT ID:
NCT00761618
Start Date:
March 2009
Completion Date:
Related Keywords:
- Advanced Cancer
- Pleural Effusion
- Intrapleural catheter
- IPC
- Pleurodesis
- PD
- Pleural effusion
- Fluid in the chest cavity
- Recurrent malignant pleural effusion
- MPE
- Pleural inflammatory response
- Pleural Effusion
- Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
