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Intrapleural Catheter Drainage Frequency for Pleural Effusion

Phase 2
Waitlist Available
Led By Carlos A. Jimenez, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must be age 18 years or over
Patients with symptomatic pleural effusion requiring placement of an IPC
Must not have
Current or prior IPC placement, or any intervention to manage recurrent malignant pleural effusion on the contralateral hemithorax (excluding thoracentesis)
Evidence of empyema or history of empyema of the affected hemithorax
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after intrapleural catheter placement
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether draining fluid from the abdomen every day is more effective than doing so 3 times a week.

Who is the study for?
This trial is for adults over 18 with symptomatic pleural effusion (fluid build-up in the chest) who need an Intrapleural Catheter (IPC). They must be able to sign a consent form. People with severe diseases, prior IPC or chest tube placements, recent thoracotomy, empyema history, bleeding issues, or conditions affecting study compliance cannot join.
What is being tested?
The study aims to determine if draining fluid from the chest using an IPC every day is more effective than doing it three times a week. Participants will have an IPC placed and their condition monitored through regular Chest X-Rays.
What are the potential side effects?
Potential side effects include discomfort at the catheter site, risk of infection, possible injury to surrounding tissues during placement or drainage procedures, and complications related to frequent chest x-rays such as radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I need a chest tube for fluid buildup in my lungs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had treatments for fluid buildup in my chest due to cancer.
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I have had an infection in the lining of my lung.
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I have had previous chest surgeries or treatments on the side of my chest with cancer.
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I have a skin infection where the IPC might be placed.
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I have a bleeding disorder that cannot be corrected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks after intrapleural catheter placement
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks after intrapleural catheter placement for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Pleurodesis (TTP)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 - 3 Times a WeekExperimental Treatment3 Interventions
IPC drained 3 times a week
Group II: Arm 1 - DailyExperimental Treatment3 Interventions
Intrapleural Catheters (IPC) drained every day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chest X-Ray
2021
N/A
~330

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,090 Total Patients Enrolled
6 Trials studying Pleural Effusion
1,763 Patients Enrolled for Pleural Effusion
CareFusionIndustry Sponsor
17 Previous Clinical Trials
19,262 Total Patients Enrolled
4 Trials studying Pleural Effusion
280 Patients Enrolled for Pleural Effusion
Carlos A. Jimenez, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
144 Total Patients Enrolled

Media Library

Intrapleural catheter (IPC) drained Clinical Trial Eligibility Overview. Trial Name: NCT00761618 — Phase 2
Pleural Effusion Research Study Groups: Arm 2 - 3 Times a Week, Arm 1 - Daily
Pleural Effusion Clinical Trial 2023: Intrapleural catheter (IPC) drained Highlights & Side Effects. Trial Name: NCT00761618 — Phase 2
Intrapleural catheter (IPC) drained 2023 Treatment Timeline for Medical Study. Trial Name: NCT00761618 — Phase 2
~24 spots leftby Aug 2026
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