Status:
RECRUITING
Pleuroscopy First Versus Thoracentesis First in Patients with Suspected Malignant Pleural Effusions
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Pleural Effusion
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
This is a randomized control trial of patients with suspected malignant pleural effusions comparing patients who undergo either pleuroscopy or thoracentesis as the first diagnostic test. Both procedur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 17 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06892691
Start Date
March 1 2025
End Date
September 17 2026
Last Update
March 25 2025
Active Locations (2)
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1
Mount Sinai West
New York, New York, United States, 10019
2
Mount Sinai Hospital
New York, New York, United States, 10029