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OpenTrials
Completed

NCT Number: NCT07478913

Predictive Value of Endobronchial Sonographic Patterns in Diagnosis of Mediastinal Lymphadenopathy

This study aims to assess the value of endosonographic patterns of EBUS bronchoscopy in diagnosis of patients with mediastinal lymphadenopathy and correlate it with the histopathological diagnosis.

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Key information

Conditions

Endobronchial Sonographic Patterns

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, Abbassia, 11511, Egypt

About this study

All patients will undergo EBUS-bronchoscopy using 22-gauge needle of EBUS.

  • Lymph node stations and numbers were determined according to the International Association for the Study of Lung Cancer classification.
  • Systemic evaluation of Lymph nodes according to ERS guidelines starting with any potential N3 lymph nodes followed by N2 lymph nodes, and N1 lymph nodes Ultrasound features of suspected lymph nodes were categorized according to: B-mode, Color Power Doppler Index (CPDI) After evaluation of ultrasound features, a TBNA using a 22- G needle were performed. Three samples were taken from each node or lesion for +/- rapid on-site evaluation ROSE (using Haematoxylin and Eosin stain) and histopathological examination.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • patients who underwent chest enhanced CT before EBUS-TBNA examination to assess the nature of mediastinal and hilar enlarged lymph nodes.

Exclusion criteria

  • Contraindication to needle biopsy (e.g. use of anticoagulation drugs, bleeding diathesis).
  • Patients unfit for bronchoscopy and general anaesthesia by international guidelines.
  • Lymph Nodes that are not accessible or technically difficult by EBUS-TBNA e.g. Station 5,6.

Treatment and study plan

Primary outcomes

  1. 1- evaluate the morphological characteristics of mediastinal LNs in real time 2- assess the nature of LNs before puncturing either benign or malignant using EBUS and corelate them with the histopathological outcome.

    Time frame: 2 years

    • EBUS sonographic features can guide the selection of LNs for biopsy
    • EBUS sonographic features can guide internal puncture site within the LN and biopsy efficiency as a complementary diagnostic value.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: EBUS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.