Optimal Number of Pleural Biopsies During Pleuroscopy (OPTIBIOP)

OPTImal Number of Pleural BIOPsies During Pleuroscopy

A single-center, non-randomized, prospective observational, pilot study designed to determine what is the optimal number of pleural biopsies to take during pleuroscopy.

Study Overview

• Status: Completed
• Conditions: Pleural Diseases

Detailed Description

After enrollment, participants will undergo pleural biopsies via pleuroscopy. Specimens will be divided into three aliquots (1-3, 4-6, 7-10), which will be sent to pathology. A designated pathologist will evaluate the specimens in each aliquot to determine the number of biopsies required to reach a diagnosis and to obtain sufficient material for biomarker testing (when needed), and determine whether analysis of further aliquots is needed.

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10028
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

All adult patients that undergo pleuroscopy for pleural biopsies, excluding those with inability to provide informed consent.

Description

Inclusion Criteria:

• Consecutive patients who require pleuroscopies will be enrolled to the study.
• Age ≥ 18

Exclusion Criteria:

- Inability to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pleural biopsy; All consecutive patients referred for a pleuroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pleural biopsies to reach a diagnosis	The number of pleural biopsies needed to reach a diagnosis.	At week 2 after pleuroscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pleural biopsies required for comprehensive biomarker testing.	The number of biopsies required to obtain sufficient material for comprehensive biomarker testing.	At week 4 after pleuroscopy
Number of complications	Number of complications related to the biopsy.	At week 4 after pleuroscopy

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Actual): December 18, 2025
• Study Completion (Actual): December 18, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Pleural effusion; Pleuroscopy; Pleural biopsy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Effusion; Pleural Diseases
• Other Study ID Numbers: STUDY-24-01325

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: Anyone who wishes to access the data. Any purpose. Proposals should be directed to jeeyune.bahk@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No