Pleural Diseases
Conditions
Keywords
Pleuroscopy, Pleural effusion, Pleural biopsy
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.
Interventions
None listed
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients who require pleuroscopies will be enrolled to the study. * Age ≥ 18
Exclusion criteria
\- Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of pleural biopsies to reach a diagnosis | At week 2 after pleuroscopy | The number of pleural biopsies needed to reach a diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 complications | At week 4 after pleuroscopy | Number of complications related to the biopsy. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORUdit Chaddha
MBBS
Outcome results
None listed