Intrapleural Catheter Daily Versus Three Times a Week Drainage - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00761618

Purpose

The investigators 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) will not result in fewer patients with pleurodesis (Pd).

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

MedlinePlus related topics: Cancer X-Rays

Drug Information available for: X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study
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

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

Primary Outcome Measures:

To learn if draining the IPC every day is better than draining it 3 times a week [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	310
Study Start Date:	August 2008
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 Radiation: Chest X-Ray Chest X-Rays at 3 and 6 month follow up visits
2: Experimental 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 Radiation: Chest X-Ray Chest X-Rays at 3 and 6 month follow up visits

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Patients with symptomatic pleural effusion requiring placement of an IPC.
Signed informed consent prior to any study related procedures.
Subject must be age 18 years or over.

Exclusion:

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.
Evidence of empyema or history of empyema of the affected hemithorax
Non-correctable bleeding diathesis
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
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.
Participation in any clinical trial that prevents randomization of the subject to either strategy.
Clinical evidence of skin infection at the potential site of IPC placement.

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

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

Responsible Party:	UT MD Anderson Cancer Center ( Carlos A. Jimenez, MD/Associate Professor )
Study ID Numbers:	2007-0808
Study First Received:	September 25, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00761618
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

intrapleural catheter
IPC
pleurodesis
Pd

pleural effusion
Recurrent malignant pleural effusion
MPE
pleural inflammatory response

Study placed in the following topic categories:

Pleural Effusion
Respiratory Tract Diseases
Pleural Diseases
Pleural Effusion, Malignant
Recurrence

ClinicalTrials.gov processed this record on January 14, 2009