MedPath

Optimal Number of Pleural Biopsies During Pleuroscopy

Recruiting
Conditions
Pleural Diseases
Registration Number
NCT06897878
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Brief Summary

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

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Consecutive patients who require pleuroscopies will be enrolled to the study.
  • Age ≥ 18
Exclusion Criteria
  • Inability to provide informed consent

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of pleural biopsies to reach a diagnosisAt week 2 after pleuroscopy

The number of pleural biopsies needed to reach a diagnosis.

Secondary Outcome Measures
NameTimeMethod
Number of pleural biopsies required for comprehensive biomarker testing.At week 4 after pleuroscopy

The number of biopsies required to obtain sufficient material for comprehensive biomarker testing.

Number of complicationsAt week 4 after pleuroscopy

Number of complications related to the biopsy.

Trial Locations

Locations (1)

Mount Sinai Hospital

🇺🇸

New York, New York, United States

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