Predictive Value of Endobronchial Sonographic Patterns in Diagnosis of Mediastinal Lymphadenopathy (EBUS)

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.

Study Overview

• Status: Completed
• Conditions: Endobronchial Sonographic Patterns

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 11511
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A prospective study comprising 50 cases patients who were admitted to bronchoscopy unit of Chest Department at Ain Shams University Hospitals with undiagnosed mediastinal lymphadenopathy.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	2 years

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Heba M shalaby, MD, Ain Shams University; Principal Investigator: Hazem HE Hammam, MSc, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): January 28, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: endobronchial sonographic patterns
• Other Study ID Numbers: FMASU MD 83/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No