Predictive Value of Endobronchial Sonographic Patterns in... | NCT07478913

Studies
Predictive Value of Endobronchial Sonographic Patterns in Diagnosis of Mediastinal Lymphadenopathy

NCT07478913

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Mar 18, 2026Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Endobronchial Sonographic Patterns

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2024Actual

Primary Completion Date

Jan 28, 2026Actual

Completion Date

Feb 28, 2026Actual

First Submitted Date

Mar 9, 2026

First Submission Date that Met QC Criteria

Mar 14, 2026

First Posted Date

Mar 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heba M shalaby, MD	Ain Shams University	Study Director
Hazem HE Hammam, MSc	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University		Cairo	Abbassia	11511	Egypt