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

NCT ID: NCT06892691

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-09-17

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.

Conditions

Pleural Effusion; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pleuroscopy first

Participants will undergo pleuroscopy first

Group Type: ACTIVE_COMPARATOR

Pleuroscopy first

Intervention Type: PROCEDURE

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.

Thoracentesis first

Participants will undergo thoracentesis first

Group Type: ACTIVE_COMPARATOR

Thoracentesis first

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Udit Chaddha

Associate Professor of Medicine and Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Udit Chaddha, MBBS

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai West

New York, New York, United States

Site Status: RECRUITING

Mount Sinai Hospital

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Udit Chaddha, MBBS

Role: CONTACT

udit.chaddha@mssm.edu

212-241-5900

Facility Contacts

Udit Chaddha, MBBS

Role: primary

Udit Chaddha, MBBS

Role: primary

udit.chaddha@mssm.edu

212-241-5900

Yekaterina Sherman, MD

Role: backup

yekaterina.sherman@mountsinai.edu

212-241-5900

Udit Chaddha, MBBS

Role: backup

Other Identifiers

STUDY-24-00999

Identifier Type: -

Identifier Source: org_study_id