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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00761618 |
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 |
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 |
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
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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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2: Experimental
IPC drained 3 times a week
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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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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contact: Carlos A. Jimenez, MD | 713-563-4252 | |
Contact: Dana Bethancourt, CCRC, RN |
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 |
Principal Investigator: | Carlos A. Jimenez, MD | UT MD Anderson Cancer Center |
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 |
intrapleural catheter IPC pleurodesis Pd |
pleural effusion Recurrent malignant pleural effusion MPE pleural inflammatory response |
Pleural Effusion Respiratory Tract Diseases Pleural Diseases Pleural Effusion, Malignant Recurrence |