Clinical trial NCT00761618: Intrapleural Catheter Daily Versus Three Times a Week Drainage
Official title: Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Advanced Cancer
Pleural Effusion
Keywords: Intrapleural catheter
IPC
Pleurodesis
PD
Pleural effusion
Fluid in the chest cavity
Recurrent malignant pleural effusion
MPE
Pleural inflammatory response
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: CareFusion
First posted: 2008-09-29
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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.

Up to 250 patients will take part in this study. All will be enrolled at MD Anderson.

Eligibility criteria: 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, or any intervention to manage recurrent malignant pleural effusion on the contralateral hemithorax (excluding thoracentesis).

Primary outcomes:
measure: Time to Pleurodesis (TTP)
timeFrame: 2 weeks after intrapleural catheter placement
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Carlos A. Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
References: