Clinical trial NCT06892691: Pleuroscopy First Versus Thoracentesis First in Patients with Suspected Malignant Pleural Effusions
Official title: Pleuroscopy First Versus Thoracentesis First in Patients with Suspected Malignant Pleural Effusions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pleural Effusion
Cancer
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to undergo either pleuroscopy first or thoracentesis first.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of biopsies adequate for definitive diagnosis
timeFrame: 6 months
Secondary outcomes:
measure: Time from initial visit with pulmonologist to procedure
timeFrame: 6 months
measure: Time from initial procedure to diagnosis
timeFrame: 6 months
measure: Time from initial visit with pulmonologist to diagnosis
timeFrame: 6 months
measure: Time from initial visit with pulmonologist to seeing oncologist
timeFrame: 6 months
measure: Time from initial visit with pulmonologist to starting treatment
timeFrame: 6 months
measure: Time from seeing oncologist to starting treatment
timeFrame: 6 months
measure: Frequency of procedure-related complications
timeFrame: 6 months
measure: Frequency of additional diagnostic testing
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Udit Chaddha, MBBS
role: PRINCIPAL_INVESTIGATOR
References: