Recruiting

Pleuroscopy vs. Thoracentesis

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06892691

Conditions

Pleural Effusion

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pleuroscopy first

Thoracentesis first

Study Details

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

Study ID

NCT06892691

Start date

Mar 24, 2025

Status verified date

Mar, 2025

Completion date

Sep 17, 2026

Anticipated

Primary completion date

Sep 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Pleuroscopy first

Participants will undergo pleuroscopy first

active comparator: Thoracentesis first

Participants will undergo thoracentesis first

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.

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.

Primary outcome measure

  • Proportion of biopsies adequate for definitive diagnosis [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Udit Chaddha, MBBS

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

Locations

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Principal Investigator:

Udit Chaddha, MBBS

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Udit Chaddha, MBBS

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

Yekaterina Sherman, MD

212-241-5900yekaterina.sherman@mountsinai.edu

Principal Investigator:

Udit Chaddha, MBBS

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Feb 4, 2026

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-02-04.