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

Not Applicable

Recruiting

• Conditions: Pleural Effusion; Cancer

• Registration Number: NCT06892691
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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

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 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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-09-17
• Study Completion: 2026-09-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of biopsies adequate for definitive diagnosis	6 months	Proportion of biopsies adequate for definitive diagnosis

Secondary Outcome Measures

Name	Time	Method
Time from initial visit with pulmonologist to diagnosis	6 months	Time from initial visit with pulmonologist to diagnosis
Time from initial visit with pulmonologist to procedure	6 months	Time from initial visit with pulmonologist to procedure
Time from initial procedure to diagnosis	6 months	Time from initial procedure to diagnosis
Time from initial visit with pulmonologist to seeing oncologist	6 months	Time from initial visit with pulmonologist to seeing oncologist
Time from initial visit with pulmonologist to starting treatment	6 months	Time from initial visit with pulmonologist to starting treatment
Time from seeing oncologist to starting treatment	6 months	Time from seeing oncologist to starting treatment
Frequency of procedure-related complications	6 months	Frequency of procedure-related complications
Frequency of additional diagnostic testing	6 months	Frequency of additional diagnostic testing

Trial Locations

Locations (2)

Mount Sinai West; 🇺🇸 New York, New York, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States