Pleuroscopy First Versus Thoracentesis First in Patients With Suspected Malignant Pleural Effusions (PERFECT-MPE)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Pleural Effusion
• Intervention / Treatment: Procedure: Pleuroscopy first; Procedure: Thoracentesis first

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 Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Udit Chaddha, MBBS; Phone Number: 212-241-5900; Email: udit.chaddha@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Udit Chaddha, MBBS; Phone Number: 212-241-5900; Email: udit.chaddha@mssm.edu
      • Contact: Yekaterina Sherman, MD; Phone Number: 212-241-5900; Email: yekaterina.sherman@mountsinai.edu
      • Principal Investigator: Udit Chaddha, MBBS
    • New York, New York, United States, 10019
      • Recruiting
      • Mount Sinai West
      • Principal Investigator: Udit Chaddha, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pleuroscopy first; Participants will undergo pleuroscopy first	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.
Active Comparator: Thoracentesis first; Participants will undergo thoracentesis first	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of biopsies adequate for definitive diagnosis	Proportion of biopsies adequate for definitive diagnosis	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from initial visit with pulmonologist to procedure	Time from initial visit with pulmonologist to procedure	6 months
Time from initial procedure to diagnosis	Time from initial procedure to diagnosis	6 months
Time from initial visit with pulmonologist to diagnosis	Time from initial visit with pulmonologist to diagnosis	6 months
Time from initial visit with pulmonologist to seeing oncologist	Time from initial visit with pulmonologist to seeing oncologist	6 months
Time from initial visit with pulmonologist to starting treatment	Time from initial visit with pulmonologist to starting treatment	6 months
Time from seeing oncologist to starting treatment	Time from seeing oncologist to starting treatment	6 months
Frequency of procedure-related complications	Frequency of procedure-related complications	6 months
Frequency of additional diagnostic testing	Frequency of additional diagnostic testing	6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Udit Chaddha, MBBS, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): September 17, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Neoplasms; Pleural Effusion
• Other Study ID Numbers: STUDY-24-00999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.

Any purpose. Proposals should be directed to udit.chaddha@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No