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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06892691
Acronym
PERFECT-MPE
Enrollment
98
Registered
2025-03-25
Start date
2025-03-24
Completion date
2026-09-17
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Pleural Effusion

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.

Interventions

PROCEDUREPleuroscopy 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.

PROCEDUREThoracentesis 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.

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Participants will be randomized to undergo either pleuroscopy first or thoracentesis first.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of biopsies adequate for definitive diagnosis6 monthsProportion of biopsies adequate for definitive diagnosis

Secondary

MeasureTime frameDescription
Time from initial visit with pulmonologist to procedure6 monthsTime from initial visit with pulmonologist to procedure
Time from initial procedure to diagnosis6 monthsTime from initial procedure to diagnosis
Time from initial visit with pulmonologist to diagnosis6 monthsTime from initial visit with pulmonologist to diagnosis
Time from initial visit with pulmonologist to starting treatment6 monthsTime from initial visit with pulmonologist to starting treatment
Time from seeing oncologist to starting treatment6 monthsTime from seeing oncologist to starting treatment
Frequency of procedure-related complications6 monthsFrequency of procedure-related complications
Time from initial visit with pulmonologist to seeing oncologist6 monthsTime from initial visit with pulmonologist to seeing oncologist
Frequency of additional diagnostic testing6 monthsFrequency of additional diagnostic testing

Countries

United States

Contacts

CONTACTUdit Chaddha, MBBS
udit.chaddha@mssm.edu212-241-5900
PRINCIPAL_INVESTIGATORUdit Chaddha, MBBS

MOUNT SINAI HOSPITAL

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026