Intrapleural Catheter Daily Versus Three Times a Week Drainage

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Care Fusion
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00761618
First received: September 25, 2008
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to Pleurodesis (TTP) [ Time Frame: 2 weeks after intrapleural catheter placement ] [ Designated as safety issue: No ]
    Time to pleurodesis (TTP), defined as the time from catheter insertion to catheter removal.


Estimated Enrollment: 280
Study Start Date: March 2009
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761618

Contacts
Contact: Carlos A. Jimenez, MD 713-563-4252
Contact: Dana Bethancourt, CCRC, RN

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Linda Foot    713-563-8841      
Principal Investigator: Carlos A. Jimenez, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Care Fusion
Investigators
Principal Investigator: Carlos A. Jimenez, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00761618     History of Changes
Other Study ID Numbers: 2007-0808, NCI-2012-01673
Study First Received: September 25, 2008
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014