NCT06892691

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pleural Effusion
• Cancer

Interventions

Type	Name	Description
PROCEDURE	Pleuroscopy first	Pleuroscopies are performed under moderate sedation with local anesthesia. Through a 1-cm incision a camera is introduced into the pleural space and the space is inspected after draining all fluid. Targeted biopsies under direct visualization are obtained using forceps. The aspirated fluid and biopsies obtained are sent to the cytology and pathology laboratories for analysis.
PROCEDURE	Thoracentesis first	Thoracenteses are performed under local anesthesia with the insertion of a 5-8Fr catheter into the pleural space. The aspirated fluid obtained is sent to the cytology laboratory for analysis.

Timeline

• Start date: 2025-03-24
• Primary completion: 2026-09-17
• Completion: 2026-09-17
• First posted: 2025-03-25
• Last updated: 2026-02-04

Locations

2 sites across 1 country: United States