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Endobronchial Ultrasound Transbronchial Needle Aspiration Of Enlarged Mediastinal In Interstitial Lung Disease

Sponsor
Sheba Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04331548
Collaborator
(none)
30
Enrollment
1
Location
44
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to assess the findings of mediastinal/hilar LN sampling by EBUS-TBNA in patients with non-sarcoidosis interstitial lung disease ( ILD) who demonstrate LN enlargement on chest imaging. Patients with non-sarcoidosis ILD referred for bronchoscopy will undergo LN sampling by EBUS-TBNA. Cytology results will be recorded along with clinico-radiologic features, BAL findings, histology and final ILD diagnosis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Study Of Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Cytology Of Enlarged Mediastinal & Hilar Lymph Nodes Detected In Interstitial Lung Disease
    Actual Study Start Date :
    May 30, 2020
    Anticipated Primary Completion Date :
    Jan 30, 2024
    Anticipated Study Completion Date :
    Jan 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. assessing the findings of mediastinal/hilar LN sampling by EBUS-TBNA in patients with non-sarcoidosis ILD who demonstrate LN enlargement on chest imaging. [during the procedure/surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. non-sarcoidosis ILD (low probably of sarcoidosis based on radiology),

    2. referred for bronchoscopy (BAL, TBLB or TBCB) in the Interventional Pulmonology Unit at Sheba Medical Center

    3. Patients with LN enlargement ≥1 cm in short diameter at stations 2, 4, 7, 10 or 11 (LN stations accessible to EBUS-TBNA)

    Exclusion Criteria:

    1. known ILD

    2. ILD with no indication to bronchoscopy

    3. contraindication to bronchoscopy .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center Ramat Gan Israel

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Liran Levy, Principal Investigator, Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT04331548
    Other Study ID Numbers:
    • SHEBA-20-7006-20-SMC-LL-CTIL
    First Posted:
    Apr 2, 2020
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Interstitial

    Study Results

    No Results Posted as of May 10, 2022