Endobronchial MassNCT07350356
Bronchoscopic Role in Early Detection of Endobronchial Tuberculosis in Suspected Pulmonary Tuberculosis Patients.
An observational study of Endobronchial Mass and Tuberculosis, Pulmonary, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate the role of bronchoscopy in diagnosis of endobronchial tuberculosis in suspected pulmonary tuberculosis patients whose sputum samples are negative for Ziehl Neelsen stain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endobronchial Mass, Tuberculosis, Pulmonary
- What is being tested?
- fiberoptic bronchoscopy evaluation of endobronchial features of TB
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 31 Aug 2024
- 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: patients will be recruited from Mansoura chest hospital for pulmonary tuberculosis suspected patients who are smear negative for acid fast bacilli.
Who may be able to join
- o Adults more than18 years.
- Accept to participate.
- Suspected pulmonary tuberculosis patients with three negative sputum samples are smear negative, and/or persistent consolidation on chest radiograph (CXR).
Who cannot join
- o Patients who refuse to participate in the study.
- Patients who are sputum Ziehl Neelsen positive.
- Patients who are diagnosed extrapulmonary tuberculosis.
- Patients who are not fit for bronchoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bronchoscopic Role in Early Detection of Endobronchial Tuberculosis in Undiagnosed Suspected Pulmonary Tuberculosis Patients.
The aim of the present study is to evaluate the role of bronchoscopy in diagnosis of endobronchial tuberculosis in suspected pulmonary tuberculosis patients whose sputum samples are negative for Ziehl Neelsen stain.
Read the detailed description
Bronchoscopy plays a major role in identification and diagnosis of EBTB. As a general principal, Bronchoscopy -associated with microbiological testing- must be performed on patients whose CT examination results indicate EBTB.
This study will try to focus on the importance of bronchoscopy in diagnosis of endobronchial tuberculosis among suspected pulmonary tuberculosis patients who undergo fiberoptic bronchoscope after being sputum Ziehl Neelsen negative, scarce sputum and/or persistent consolidation on chest radiograph (CXR).
- Conditions
- Endobronchial Mass, Tuberculosis, Pulmonary
- Being tested
- fiberoptic bronchoscopy evaluation of endobronchial features of TB
- Keywords
- Fiberoptic bronchoscopy, Endobronchial TB, Smear negative TB, Suspected PTB
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic bronchoscopy evaluation of endobronchial features of TBDiagnostic test
EBTB was classified into seven subtypes by using the Chung's method: actively caseating, fibrostenotic, oedematous-hyperaemic, tumorous, ulcerative, granular, and the non-specific bronchitic subtype.
| Study group | Role | What they receive |
|---|---|---|
| group 1: PTB with concomitant EBTB, group 2: PTB with no concomitant EBTB. | group 1of 41 patients had positive bronchoscopic findings of PTB with concomitant of EBTB, group 2 of 22 patients had PTB with no concomitant EBTB. Receives: Diagnostic Test: fiberoptic bronchoscopy evaluation of endobronchial features of TB |
What is being measured
The primary outcome is the main question the study is designed to answer.
the role of fiberoptic bronchoscopy in sputum smear negative and radiologically suspected pulmonary tuberculosis 63 patients in Mansoura chest hospital, bronchoscopy unit for early detection of endobronchial tuberculosis.
bronchoscopic evaluation of tracheobronchial tree for endobronchial tuberculosis lesions in patients with suspected PTB
Measured: 1 year
Secondary outcomes (1)
The clinical presentation, bronchoscopic characteristics in comparison to radiological characteristics of EBTB, and incidence of EBTB subtypes in pulmonary TB patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Sep 2023
- Primary completion29 Feb 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endobronchial MassStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 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, Principal investigator, Ain Shams University, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350356
- Sponsor's protocol ID
- FMASU MD 203/2023
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication maybe shared
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Role in Early Detection of Endobronchial Tuberculosis in Undiagnosed Suspected Pulmonary Tuberculosis Patients.
- ClinicalTrials.gov ID
- NCT07350356
- Acronym / sponsor ID
- FMASU MD 203/2023
- Conditions
- Endobronchial Mass, Tuberculosis, Pulmonary
- Keywords
- Fiberoptic bronchoscopy, Endobronchial TB, Smear negative TB, Suspected PTB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 20 Jan 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.
The aim of the present study is to evaluate the role of bronchoscopy in diagnosis of endobronchial tuberculosis in suspected pulmonary tuberculosis patients whose sputum samples are negative for Ziehl Neelsen stain.
Detailed description
Bronchoscopy plays a major role in identification and diagnosis of EBTB. As a general principal, Bronchoscopy -associated with microbiological testing- must be performed on patients whose CT examination results indicate EBTB.
This study will try to focus on the importance of bronchoscopy in diagnosis of endobronchial tuberculosis among suspected pulmonary tuberculosis patients who undergo fiberoptic bronchoscope after being sputum Ziehl Neelsen negative, scarce sputum and/or persistent consolidation on chest radiograph (CXR).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1: PTB with concomitant EBTB, group 2: PTB with no concomitant EBTB. | – | Diagnostic Test: fiberoptic bronchoscopy evaluation of endobronchial features of TBgroup 1of 41 patients had positive bronchoscopic findings of PTB with concomitant of EBTB, group 2 of 22 patients had PTB with no concomitant EBTB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients will be recruited from Mansoura chest hospital for pulmonary tuberculosis suspected patients who are smear negative for acid fast bacilli.
Key inclusion criteria (3 listed)
- o Adults more than18 years.
Key exclusion criteria (4 listed)
- o Patients who refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fiberoptic bronchoscopy evaluation of endobronchial features of TBEBTB was classified into seven subtypes by using the Chung's method: actively caseating, fibrostenotic, oedematous-hyperaemic, tumorous, ulcerative, granular, and the non-specific bronchitic subtype. | Diagnostic test | group 1: PTB with concomitant EBTB, group 2: PTB with no concomitant EBTB. |
Primary outcome
the role of fiberoptic bronchoscopy in sputum smear negative and radiologically suspected pulmonary tuberculosis 63 patients in Mansoura chest hospital, bronchoscopy unit for early detection of endobronchial tuberculosis.
Time frame: 1 year
bronchoscopic evaluation of tracheobronchial tree for endobronchial tuberculosis lesions in patients with suspected PTB
1 secondary outcome
The clinical presentation, bronchoscopic characteristics in comparison to radiological characteristics of EBTB, and incidence of EBTB subtypes in pulmonary TB patients
Time frame: 1 year
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 20 Jan 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication maybe shared
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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 principal investigator
Ain Shams University, Faculty of medicine
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 Mass and Tuberculosis, Pulmonary, 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 3 inclusion and 4 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 20 Jan 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?
the role of fiberoptic bronchoscopy in sputum smear negative and radiologically suspected pulmonary tuberculosis 63 patients in Mansoura chest hospital, bronchoscopy unit for early detection of endobronchial tuberculosis. (time frame: 1 year). 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 20 Jan 2026.