Endobronchial Sonographic PatternsEBUSNCT07478913
Predictive Value of Endobronchial Sonographic Patterns in Diagnosis of Mediastinal Lymphadenopathy
An observational study of Endobronchial Sonographic Patterns, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endobronchial Sonographic Patterns
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2024to 28 Feb 2026
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Age ≥ 18 years.
- patients who underwent chest enhanced CT before EBUS-TBNA examination to assess the nature of mediastinal and hilar enlarged lymph nodes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Endobronchial Sonographic Patterns
- Keywords
- endobronchial sonographic patterns
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start30 May 2024
- Primary completion28 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endobronchial Sonographic PatternsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heba M shalaby, MD, Study director, Ain Shams UniversityHazem HE Hammam, MSc, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478913
- Sponsor's protocol ID
- FMASU MD 83/2024
- Acronym
- EBUS
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Endobronchial Sonographic Patterns in Diagnosis of Mediastinal Lymphadenopathy
- ClinicalTrials.gov ID
- NCT07478913
- Acronym / sponsor ID
- EBUS / FMASU MD 83/2024
- Conditions
- Endobronchial Sonographic Patterns
- Keywords
- endobronchial sonographic patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Age ≥ 18 years.
- patients who underwent chest enhanced CT before EBUS-TBNA examination to assess the nature of mediastinal and hilar enlarged lymph nodes.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba M shalaby, MD study director
Ain Shams University
Hazem HE Hammam, MSc principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endobronchial Sonographic Patterns, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.