Intrapleural Catheter Drainage Frequency for Pleural Effusion

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Empyema, Uncontrolled disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

257 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the use of indwelling pleural catheters (IPC) generally safe for humans?

Indwelling pleural catheters (IPC) are generally considered safe for managing pleural effusions, though complications like infections and blockages can occur. Studies suggest IPCs are safe compared to other treatments, but it's important to monitor for any issues. ^{1 2 3 4 5}

How is the intrapleural catheter (IPC) treatment for pleural effusion different from other treatments?

The intrapleural catheter (IPC) treatment is unique because it allows for continuous drainage of pleural fluid at home, which can be more convenient and less invasive than repeated hospital visits for fluid removal. Unlike other treatments, IPCs can also help achieve pleurodesis (the fusion of the lung to the chest wall to prevent fluid buildup) and can be removed once the effusion resolves. ^{4 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Carlos A. Jimenez, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Signed informed consent prior to any study related procedures

I need a chest tube for fluid buildup in my lungs.

Exclusion Criteria

Participation in any clinical trial that prevents randomization of the subject to either strategy

Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

I have had treatments for fluid buildup in my chest due to cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

IPC Placement

Participants will have an intrapleural catheter (IPC) placed to drain pleural effusions

1 day

1 visit (in-person)

Treatment

Participants are assigned to either daily or three times a week IPC drainage

2 weeks

1 visit (in-person) for follow-up

Follow-up

Participants return every 4 weeks for follow-up visits until IPC removal, and additional follow-ups at 3 and 6 months post-removal

6 months

Multiple visits (in-person and remote)

Treatment Details

Interventions

• Intrapleural catheter (IPC) drained
• IPC Placement

Trial Overview 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.

Participant Groups

Group I: Arm 2 - 3 Times a Week Experimental Treatment 3 Interventions

IPC drained 3 times a week

Group II: Arm 1 - Daily Experimental Treatment 3 Interventions

Intrapleural Catheters (IPC) drained every day

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

CareFusion

Industry Sponsor

Trials

18

Recruited

19,500+

Findings from Research

A study involving 104 patients found that the insertion of indwelling pleural catheters (IPC) is safe for patients undergoing chemotherapy, with no significant increase in pleural infections compared to those not receiving chemotherapy.

Patients receiving chemotherapy had a significantly lower six-month mortality rate compared to those not on chemotherapy, suggesting that IPC management during chemotherapy may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. Hak, CC., Sivakumar, P., Ahmed, L.[2018]

Indwelling pleural catheters (IPCs) are a safe option for managing recurrent pleural effusions, with complications occurring in less than 5% of patients, typically manageable with antibiotics.

While IPCs can lead to issues like pleural loculations in 10% of patients, these can often be treated effectively with intrapleural fibrinolytic therapy, highlighting the importance of ongoing management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of indwelling pleural catheter use and their management. Lui, MM., Thomas, R., Lee, YC.[2018]

Indwelling pleural catheters (IPCs) have a high pleurodesis rate of 74% for treating benign pleural effusions, with factors like a performance status score of ≤2 and medical thoracoscopy significantly increasing the likelihood of successful pleurodesis.

Certain conditions, such as secondary pleural infection and connective tissue disease, can lead to earlier removal of IPCs, while complications like liver and heart failure can delay removal, indicating the importance of patient factors in managing IPC therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Predictors of Successful and Earlier Removal of Indwelling Pleural Catheters in Benign Pleural Effusions. Li, P., Hosseini, S., Zhang, T., et al.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Complications after Indwelling Pleural Catheter Implant for Symptomatic Recurrent Benign and Malignant Pleural Effusions]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Safety of indwelling pleural catheter use in patients undergoing chemotherapy: a five-year retrospective evaluation. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Complications of indwelling pleural catheter use and their management. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Predictors of Successful and Earlier Removal of Indwelling Pleural Catheters in Benign Pleural Effusions. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Re-establishing indwelling pleural catheter patency with alteplase after failure of streptokinase. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Intrapleural Fibrinolysis for the Treatment of Indwelling Pleural Catheter-Related Symptomatic Loculations: A Multicenter Observational Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

High-pressure leakage of pleural fluid through the healed entry site of the indwelling pleural catheter from undrained locules. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Successful treatment of a complex malignant pleural effusion with 1 mg alteplase instilled through a non-draining indwelling pleural catheter. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Intrapleural Fibrinolytics and Deoxyribonuclease for Treatment of Indwelling Pleural Catheter-Related Pleural Infection: A Multi-Center Observational Study. [2021]