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Intrapleural Catheter Daily Versus Three Times a Week Drainage

This study is currently recruiting participants.
Verified January 2013 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00761618
First received: September 25, 2008
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  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.

Objectives:

Primary Objective:

Our primary objective is to show that draining the intrapleural catheter (IPC) every day (study arm ED) rather than 3 days a week (study arm TDW) results in an earlier removal of the catheter.

Secondary Objectives:

To compare on each drainage strategy:

1.1 Incidence of pleurodesis. 1.2 Survival after IPC insertion. 1.3 Incidence of secondary failures after IPC removal. 1.4 Incidence of partially successful pleurodesis. 1.5 Incidence of intrapleural catheter related infections. 1.6 Incidence of intrapleural catheter occlusions. 1.7 Incidence of other complications (bleeding, pneumothorax, persistent ipsilateral chest pain after IPC insertion).

1.8 Distance in meters on a six-minute walk test (6MWT) before IPC insertion, after approximately 2 weeks and at the time of removal.

1.9 Estimated adequate lung re-expansion visualized on radiological studies immediately after IPC insertion, after approximately 2 weeks and at the time of removal 1.10 ECOG performance status before IPC insertion, after approximately 2 weeks and at the time of removal (Appendix A).

1.11 Palliation of dyspnea using St. George's respiratory questionnaire. (Appendix B).

1.12 Quality of life using the EuroQOL (EQ-5D, Appendix D). 1.13 To compare on pleural fluid samples D-Dimer, TNF-alpha, TGF-beta1, VEGF, PAI-1 and IL-8, at the time of IPC placement, and within 12 to 72 hours, two weeks, and at the time of IPC removal.

1.14 Total number of pleural fluid drainages using the intrapleural catheter.


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:

MedlinePlus related topics: Cancer X-Rays
U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of Patients with Pleurodesis (Pd) [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: March 2009
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - Daily
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 - 3xWeek
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 on the contralateral hemithorax.
  Contacts and Locations
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
UT 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
Investigators
Principal Investigator: Carlos A. Jimenez, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00761618     History of Changes
Other Study ID Numbers: 2007-0808
Study First Received: September 25, 2008
Last Updated: January 23, 2013
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
Neoplasms
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013