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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
98
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.
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.
Mount Sinai West
New York, New York, United States
RECRUITINGMount Sinai Hospital
New York, New York, United States
RECRUITINGProportion of biopsies adequate for definitive diagnosis
Proportion of biopsies adequate for definitive diagnosis
Time frame: 6 months
Time from initial visit with pulmonologist to procedure
Time from initial visit with pulmonologist to procedure
Time frame: 6 months
Time from initial procedure to diagnosis
Time from initial procedure to diagnosis
Time frame: 6 months
Time from initial visit with pulmonologist to diagnosis
Time from initial visit with pulmonologist to diagnosis
Time frame: 6 months
Time from initial visit with pulmonologist to seeing oncologist
Time from initial visit with pulmonologist to seeing oncologist
Time frame: 6 months
Time from initial visit with pulmonologist to starting treatment
Time from initial visit with pulmonologist to starting treatment
Time frame: 6 months
Time from seeing oncologist to starting treatment
Time from seeing oncologist to starting treatment
Time frame: 6 months
Frequency of procedure-related complications
Frequency of procedure-related complications
Time frame: 6 months
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Frequency of additional diagnostic testing
Frequency of additional diagnostic testing
Time frame: 6 months