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

NCT06892691 | Recruiting

• 1 other identifier: STUDY-24-00999
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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.

Conditions

Pleural Effusion; Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of biopsies adequate for definitive diagnosis

  Proportion of biopsies adequate for definitive diagnosis

  6 months

Secondary Outcomes (8)

• Time from initial visit with pulmonologist to procedure

  6 months

• Time from initial procedure to diagnosis

  6 months

• Time from initial visit with pulmonologist to diagnosis

  6 months

• Time from initial visit with pulmonologist to seeing oncologist

  6 months

• Time from initial visit with pulmonologist to starting treatment

  6 months

Study Arms (2)

Pleuroscopy first

ACTIVE COMPARATOR

Participants will undergo pleuroscopy first

Procedure: Pleuroscopy first

Thoracentesis first

ACTIVE COMPARATOR

Participants will undergo thoracentesis first

Procedure: Thoracentesis first

Interventions

Pleuroscopy first 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.

Pleuroscopy first

Thoracentesis first 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.

Thoracentesis first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Pleural Effusion; Neoplasms

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Udit Chaddha, MBBS

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Udit Chaddha, MBBS

CONTACT

212-241-5900; udit.chaddha@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Thoracic Surgery

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

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): September 17, 2026
• Last Updated: February 4, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• 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).

Locations

US (2)