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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether draining fluid from the chest daily or three times a week is more effective for individuals with pleural effusion, a condition where excess fluid accumulates around the lungs. Participants will use an intrapleural catheter, a small tube in the chest, to aid in fluid drainage. The trial targets individuals who already experience symptoms from pleural effusion and require a catheter but have not undergone certain chest procedures or had infections. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

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.

What prior data suggests that intrapleural catheter drainage is safe for pleural effusion?

Research has shown that using tubes called intrapleural catheters (IPCs) to drain fluid from around the lungs is generally safe. Studies indicate that infections at the catheter site occur in less than 5% of patients, and most of these infections can be treated without removing the catheter.

The most common problems with IPCs are blockages in the tube and the tube moving out of place, occurring in about 6% to 7% of cases. Overall, IPCs are considered a reliable method for managing fluid buildup around the lungs, with manageable risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different drainage frequencies for intrapleural catheters (IPC) in managing pleural effusion, a condition where excess fluid builds up between the layers of the pleura outside the lungs. Unlike the typical approaches that might involve thoracentesis or indwelling pleural catheters with varied drainage protocols, this trial specifically compares draining IPCs daily versus three times a week to optimize both effectiveness and patient comfort. By focusing on the impact of drainage frequency, the trial aims to find the most efficient way to relieve symptoms, reduce complications, and improve quality of life for patients with pleural effusion.

What evidence suggests that this trial's treatments could be effective for pleural effusion?

Studies have shown that intrapleural catheters (IPCs) effectively relieve symptoms like shortness of breath and improve the quality of life for patients with pleural effusions, a condition where fluid accumulates around the lungs. This trial will assign participants to different arms to test drainage frequency: one group will have the IPC drained daily, while another will have it drained three times a week. Research indicates that drainage frequency can affect outcomes. Patients often experience "spontaneous pleurodesis," where fluid stops accumulating after using the catheter. Infections can occur rarely, but they are usually treatable with antibiotics. Overall, IPCs are considered a reliable method for managing pleural effusions. ^{4 6 7 8 9}

Who Is on the Research Team?

Carlos A. Jimenez, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

C. R. Bard

Industry Sponsor

Trials

109

Recruited

40,200+

Timothy M. Ring

C. R. Bard

Chief Executive Officer since 2003

Bachelor of Science in Industrial and Labor Relations from Cornell University

Dr. Cimler

C. R. Bard

Chief Medical Officer since 2017

Ph.D. in Pharmacology

CareFusion

Industry Sponsor

Trials

18

Recruited

19,500+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11986789/

Clinical outcomes of caregiver-led indwelling pleural ... In this study, we sought to evaluate IPC outcomes and complication rates in patients for whom IPC care and home drainage are performed by family members and ...

2. jtd.amegroups.org jtd.amegroups.org/article/view/21762/html

Indwelling pleural catheters: complications and management ... IPCs uniformly relieve dyspnea and improve quality of life of patients with malignant pleural effusions. In some patients with recurrent non-malignant pleural ...

3. mdanderson.org mdanderson.org/content/dam/mdanderson/documents/for-physicians/algorithms/clinical-management/clin-management-intrapleural-catheters-web-algorithm.pdf

Intrapleural Catheter (IPC) Management Randomized trial of pleural fluid drainage frequency in patients with malignant pleural effusions. The ASAP Trial. American Journal of ...

4. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.201908-615OC

Indwelling Pleural Catheter Drainage Strategy for ... After IPC placement, a significant proportion of patients achieve “spontaneous pleurodesis,” which is characterized by sustained resolution of ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0012369213607369

Clinical Outcomes of Indwelling Pleural Catheter-Related ... Only 50 patients (4.9%) developed an IPC-related pleural infection; most (94%) were successfully controlled with antibiotics (62% IV). One death (2%) directly ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6105989/

Indwelling pleural catheters: complications and ... Fysh et al. reported that the majority of pleural infections (54.0%, n=27) were successfully managed without removing the IPC. Of the 23 IPCs removed in an ...

7. bmjopenrespres.bmj.com bmjopenrespres.bmj.com/content/3/1/e000123

Complications of indwelling pleural catheter use and their ... IPC use is safe compared to talc pleurodesis, though complications can occur. Pleural infection affects <5% of patients, and is usually responsive to ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0012369221044330

The Frequency, Risk Factors, and Management of ... Drain blockage and displacement were the most common complications following intercostal drain insertion (6.3% and 6.8%, respectively). IPC-related infections ...

9. jtd.amegroups.org jtd.amegroups.org/article/view/84584/html

Indwelling pleural catheter infection and colonisation Indwelling pleural catheters (IPCs) are used in the management of malignant pleural effusions, but they can become infected in 5.7% of cases.