Bronchoscopic Role in Early Detection of Endobronchial Tuberculosis in Suspected Pulmonary Tuberculosis Patients.

NCT07350356 | Completed DMC

• 1 other identifier: FMASU MD 203/2023
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberculosis, Pulmonary; Endobronchial Mass

Keywords

Fiberoptic bronchoscopy; Endobronchial TB; Smear negative TB; Suspected PTB

Outcome Measures

Primary Outcomes (1)

• 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

  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

  1 year

Study Arms (1)

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.

Diagnostic Test: fiberoptic bronchoscopy evaluation of endobronchial features of TB

Interventions

fiberoptic bronchoscopy evaluation of endobronchial features of TB DIAGNOSTIC_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.

group 1: PTB with concomitant EBTB, group 2: PTB with no concomitant EBTB.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients will be recruited from Mansoura chest hospital for pulmonary tuberculosis suspected patients who are smear negative for acid fast bacilli.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Heba Shalaby

Cairo, 11511, Egypt

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Heba M Shalaby, MD

  Ain Shams University, Faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 20, 2026
• Study Start: September 1, 2023
• Primary Completion: February 29, 2024
• Study Completion: August 31, 2024
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year
• Access Criteria: personal request

Locations

EG (1)