Comparing pleuroscopy and thoracentesis for diagnosing malignant pleural effusions
Pleuroscopy First Versus Thoracentesis First in Patients With Suspected Malignant Pleural Effusions
NA · Icahn School of Medicine at Mount Sinai · NCT06892691
This study is testing whether pleuroscopy or thoracentesis is better for diagnosing cancer in patients with fluid buildup in the chest.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06892691 on ClinicalTrials.gov |
What this trial studies
This randomized control trial aims to determine whether pleuroscopy or thoracentesis is more effective as the first diagnostic procedure for patients with suspected malignant pleural effusions. Participants will be randomly assigned to undergo either pleuroscopy or thoracentesis first, with the goal of assessing which method yields more adequate biopsy samples and leads to a quicker diagnosis and initiation of cancer treatment. Standard imaging techniques, such as ultrasound and chest x-ray, will be utilized as part of the procedure, but no additional research imaging will be performed. The study will also evaluate the need for further diagnostic steps if the initial procedure is inconclusive.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are referred for a diagnostic pleural procedure due to suspected malignant pleural effusion.
Not a fit: Patients who have a known malignant pleural effusion or those with other specific conditions that preclude participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses for patients with suspected malignant pleural effusions, facilitating timely oncologic treatment.
How similar studies have performed: While both pleuroscopy and thoracentesis are standard procedures, this study's direct comparison of their effectiveness as first-line diagnostics is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Referral for diagnostic pleural procedure. * Age ≥ 18 years. * Suspected malignant pleural effusion (Suggestive radiologic appearance (based on computed tomography or positron emission tomography) OR suspected cancer with associated effusion.) Exclusion Criteria: * Inability to provide informed consent. * Needs emergent drainage. * Pleural effusion is known to be malignant. * Suspected transudative, infectious or inflammatory effusion etiology. * Having prior inconclusive/non-diagnostic thoracentesis or pleuroscopy. * Patient is deemed by the clinical team to be more appropriate for VATS biopsy. * Terminally ill patients in whom a diagnosis will not change management, or who is unlikely to be a candidate for oncological treatment due to significant comorbidities. * Pregnancy
Where this trial is running
New York, New York and 1 other locations
- Mount Sinai West — New York, New York, United States (RECRUITING)
- Mount Sinai Hospital — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Udit Chaddha, MBBS — MOUNT SINAI HOSPITAL
- Study coordinator: Udit Chaddha, MBBS
- Email: udit.chaddha@mssm.edu
- Phone: 212-241-5900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pleural Effusion, Cancer