Comparing Pleuroscopy First vs. Thoracentesis First for Suspected Malignant Pleural Effusions

This study is for people with suspected malignant pleural effusions (fluid around the lungs that might be due to cancer). It compares two common procedures: pleuroscopy first or thoracentesis first. A pleuroscopy involves a small incision to insert a camera and take targeted biopsies (tissue samples). A thoracentesis involves inserting a small tube to drain fluid for analysis. The study wants to see if starting with a pleuroscopy helps patients get an adequate biopsy, a diagnosis, and start cancer treatment faster than starting with a thoracentesis. You can join if you are 18 or older and have suspected malignant pleural effusion. The study will measure the proportion of biopsies that are good enough for a clear diagnosis after 6 months. The current recruitment status is unclear.

Study design
This is a randomized control trial comparing two procedures in 98 participants. Participants will be randomly assigned to either the pleuroscopy first or thoracentesis first group.
What's involved
You would undergo either a pleuroscopy or a thoracentesis as your first diagnostic procedure. An ultrasound is used before and a chest X-ray after the procedure.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, proportion of adequate biopsies, is measured at 6 months.

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NCT06892691

Pleuroscopy First Versus Thoracentesis First in Patients With Suspected Malignant Pleural Effusions

Recruiting
NAAges 18+InterventionalDiagnostic
Icahn School of Medicine at Mount Sinai
~98 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Pleuroscopy firstThoracentesis first

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of biopsies adequate for definitive diagnosis
Measured over 6 months
Pleural Effusion
Cancer
2 sites across 1 states
New York2
  • Udit Chaddha, MBBS · PRINCIPAL_INVESTIGATOR · MOUNT SINAI HOSPITAL

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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
  • Proportion of biopsies adequate for definitive diagnosis6 months

    Proportion of biopsies adequate for definitive diagnosis