Thoracentesis vs Pleuroscopy for Cancer

(PERFECT-MPE Trial)

Recruiting at 1 trial location

Overseen By Udit Chaddha, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Known malignant effusion, Terminal illness, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

98 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized control trial of patients with suspected malignant pleural effusions to compare whether patients who have a thoracentesis or pleuroscopy (pleural biopsy) obtain an adequate biopsy, achieve a diagnosis, and begin cancer-directed therapy faster.

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 data supports the effectiveness of the treatment Pleuroscopy and Thoracentesis for cancer?

Pleuroscopy (a procedure to look inside the chest) is effective in diagnosing and treating pleural effusions (fluid build-up) related to cancer, often providing a quick diagnosis and allowing for treatment like pleurodesis (a procedure to prevent fluid build-up). Thoracentesis (removing fluid from the chest) is useful for diagnosing pleural effusions, especially in cancer patients, and can guide further treatment decisions. ^{1 2 3 4 5}

How does the treatment Pleuroscopy differ from other treatments for malignant pleural effusion?

Pleuroscopy is unique because it allows direct visualization of the pleural space and can be used for both diagnosis and treatment, such as performing pleurodesis (a procedure to prevent fluid buildup) with talc. This approach is more effective in preventing recurrence of pleural effusion compared to thoracentesis, which is primarily diagnostic and provides only temporary relief. ^{1 3 4 6 7}

Research Team

Udit Chaddha, MBBS

Principal Investigator

MOUNT SINAI HOSPITAL

Eligibility Criteria

This trial is for patients who are suspected to have malignant pleural effusions, which is a condition where there's abnormal fluid buildup around the lungs often linked to cancer. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am referred for a procedure to diagnose pleural issues.

I might have fluid in my chest from cancer, shown on scans.

Exclusion Criteria

I am unable to understand or sign the consent form.

Having prior inconclusive/non-diagnostic thoracentesis or pleuroscopy

My pleural effusion is cancerous.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Procedure

Participants undergo either pleuroscopy or thoracentesis as the first diagnostic test

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial procedure

6 months

Regular follow-up visits as needed

Treatment Details

Interventions

• Pleuroscopy
• Thoracentesis

Trial Overview The study aims to determine if starting with thoracentesis (fluid removal) or pleuroscopy (biopsy of the lining around the lungs) leads to quicker and more effective diagnosis and initiation of treatment for cancer-related fluid buildup in the chest.

Participant Groups

Group I: Pleuroscopy first Active Control 1 Intervention

Participants will undergo pleuroscopy first

Group II: Thoracentesis first Active Control 1 Intervention

Participants will undergo thoracentesis first

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Sensitivity and complications of thoracentesis and thoracoscopy: a meta-analysis. [2023]

2. Spain pubmed.ncbi.nlm.nih.gov

[Thoracocentesis for the assessment of lung cancer with pleural effusion]. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Sensitivity of Initial Thoracentesis for Malignant Pleural Effusion Stratified by Tumor Type in Patients with Strong Evidence of Metastatic Disease. [2019]

4. Belgium pubmed.ncbi.nlm.nih.gov

[Role of clinical thoracoscopy in the diagnosis and treatment of pleuropulmonary cancer]. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Current diagnostic approach to pleural effusion]. [2009]

6. Turkey pubmed.ncbi.nlm.nih.gov

The cell block method increases the diagnostic yield in exudative pleural effusions accompanying lung cancer. [2022]

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

Video-thoracoscopic surgical pleurodesis in the management of malignant pleural effusion: the importance of an early intervention. [2022]