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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06892691
Status
Recruiting
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Conditions

  • Cancer
  • Pleural Effusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Mar 24, 2025
Status verified
Mar 2025
Primary completion
Sep 17, 2026
Completion
Sep 17, 2026

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Pleuroscopy first
    Participants will undergo pleuroscopy first
  • Active Comparator: Thoracentesis first
    Participants will undergo thoracentesis first

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Udit Chaddha, MBBS
[email protected]
212-241-5900
Yekaterina Sherman, MD
[email protected]
212-241-5900
Udit Chaddha, MBBS (PRINCIPAL_INVESTIGATOR)
Mount Sinai WestNew YorkNew York10019
Udit Chaddha, MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Hospital· New York, NYMount Sinai West· New York, NY

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