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

Last updated: March 19, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Pleural Effusion

Lung Disease

Treatment

Pleuroscopy first

Thoracentesis first

Clinical Study ID

NCT06892691
STUDY-24-00999
  • Ages > 18
  • All Genders

Study 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, achieve a diagnosis, and begin cancer-directed therapy faster.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Referral for diagnostic pleural procedure.

  • Age ≥ 18 years.

  • Suspected malignant pleural effusion (Suggestive radiologic appearance (based oncomputed tomography or positron emission tomography) OR suspected cancer withassociated effusion.)

Exclusion

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 isunlikely to be a candidate for oncological treatment due to significantcomorbidities.

  • Pregnancy

Study Design

Total Participants: 98
Treatment Group(s): 2
Primary Treatment: Pleuroscopy first
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
September 17, 2026

Study 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 procedures are considered standard of care for this diagnosis but it is unknown which one provides more adequate biopsy samples and achieves faster diagnosis and shorter time to oncologic treatment. Currently, most patients undergo thoracentesis first and, if this is inadequate for diagnosis, they then undergo pleuroscopy for further biopsy samples. This study seeks to assess whether patients who undergo pleuroscopy as the first test obtain adequate biopsy samples and a faster path to further oncologic care compared to patients who undergo thoracentesis first. Patients will be recruited and randomized in a 1:1 manner.

Ultrasound is routinely used prior to the procedure and a chest x-ray is done after the procedure. Any other imaging will be determined by clinic need only. No imaging will be done for research purposes. No additional samples will be collected other than what is necessary for diagnostic purposes. In patients who have a non-diagnostic thoracentesis, the participants will be referred for pleuroscopy as the next diagnostic step. In the rare case that pleuroscopy does not achieve adequate diagnosis, the next step would be a liquid biopsy (non-invasive serologic testing for oncologic markers.) The need for liquid biopsy in participants in this study will be determined on a case-by-case basis depending on the clinical concern for malignancy.

Connect with a study center

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • Mount Sinai West

    New York, New York 10019
    United States

    Active - Recruiting

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