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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

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 .

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04331548
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sheba Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Interstitial Lung Disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, ,