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NCT04331548 Clinical Trial

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

Interstitial Lung Disease Clinical Trial

Official title:
Study Of Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Cytology Of Enlarged Mediastinal & Hilar Lymph Nodes Detected In Interstitial Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04331548
Other study ID # SHEBA-20-7006-20-SMC-LL-CTIL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2020
Est. completion date January 30, 2024

Study information
Verified date May 2022
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date January 30, 2024
Est. primary completion date January 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 .

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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