Predictive Value of Endobronchial Sonographic Patterns in Diagnosis of Mediastinal Lymphadenopathy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07478913

Acronym

EBUS

Enrollment

Registered

2026-03-18

Start date

2024-05-30

Completion date

2026-02-28

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endobronchial Sonographic Patterns

Keywords

endobronchial sonographic patterns

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.	2 years	1. EBUS sonographic features can guide the selection of LNs for biopsy 2. EBUS sonographic features can guide internal puncture site within the LN and biopsy efficiency as a complementary diagnostic value.

Countries

Egypt

Contacts

STUDY_DIRECTORHeba M shalaby, MD

Ain Shams University

PRINCIPAL_INVESTIGATORHazem HE Hammam, MSc