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Intrapleural Catheter Daily Versus Three Times a Week Drainage

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ClinicalTrials.gov Identifier: NCT00761618
Recruitment Status : Active, not recruiting
First Posted : September 29, 2008
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
CareFusion
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Pleural Effusion Procedure: Intrapleural catheter (IPC) drained Procedure: IPC Placement Radiation: Chest X-Ray Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2009
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: Arm 1 - Daily
Intrapleural Catheters (IPC) drained every day
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

Experimental: Arm 2 - 3 Times a Week
IPC drained 3 times a week
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761618


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
CareFusion
Investigators
Principal Investigator: Carlos A. Jimenez, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00761618     History of Changes
Other Study ID Numbers: 2007-0808
NCI-2012-01673 ( Registry Identifier: NCI CTRP )
First Posted: September 29, 2008    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Intrapleural catheter
IPC
Pleurodesis
PD
Pleural effusion
Fluid in the chest cavity
Recurrent malignant pleural effusion
MPE
Pleural inflammatory response

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases