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Intrapleural Catheter Daily Versus Three Times a Week Drainage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00761618
Recruitment Status : Active, not recruiting
First Posted : September 29, 2008
Last Update Posted : August 26, 2022
Sponsor:
Collaborator:
CareFusion
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE September 25, 2008
First Posted Date  ICMJE September 29, 2008
Last Update Posted Date August 26, 2022
Actual Study Start Date  ICMJE August 22, 2008
Estimated Primary Completion Date August 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
To learn if draining the IPC every day is better than draining it 3 times a week [ Time Frame: 3 Years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intrapleural Catheter Daily Versus Three Times a Week Drainage
Official Title  ICMJE Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Pleural Effusion
Intervention  ICMJE
  • Procedure: Intrapleural catheter (IPC) drained
    IPC drained daily (Group 1) or 3 times per week (Group 2)
  • Procedure: IPC Placement
    IPC placed in chest cavity to drain excess fluid
    Other Name: Indwelling Pleural Catheter
  • Radiation: Chest X-Ray
    Chest X-Rays at 3 and 6 month follow up visits
Study Arms  ICMJE
  • Experimental: Arm 1 - Daily
    Intrapleural Catheters (IPC) drained every day
    Interventions:
    • Procedure: Intrapleural catheter (IPC) drained
    • Procedure: IPC Placement
    • Radiation: Chest X-Ray
  • Experimental: Arm 2 - 3 Times a Week
    IPC drained 3 times a week
    Interventions:
    • Procedure: Intrapleural catheter (IPC) drained
    • Procedure: IPC Placement
    • Radiation: Chest X-Ray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 25, 2022)
257
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2008)
310
Estimated Study Completion Date  ICMJE August 31, 2024
Estimated Primary Completion Date August 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00761618
Other Study ID Numbers  ICMJE 2007-0808
NCI-2012-01673 ( Registry Identifier: NCI CTRP-Clinical Trials Reporting Registry )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party M.D. Anderson Cancer Center
Original Responsible Party Carlos A. Jimenez, MD/Associate Professor, UT MD Anderson Cancer Center
Current Study Sponsor  ICMJE M.D. Anderson Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE CareFusion
Investigators  ICMJE
Principal Investigator: Carlos A. Jimenez, MD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP