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

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis, Pulmonary; Endobronchial Mass
• Intervention / Treatment: Diagnostic test: fiberoptic bronchoscopy evaluation of endobronchial features of TB

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 Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11511
    • Heba Shalaby

Participation Criteria

Eligibility Criteria

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

• 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.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The clinical presentation, bronchoscopic characteristics in comparison to radiological characteristics of EBTB, and incidence of EBTB subtypes in pulmonary TB patients	1 year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Heba M Shalaby, MD, Ain Shams University, Faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: December 20, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Fiberoptic bronchoscopy; Endobronchial TB; Smear negative TB; Suspected PTB
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: FMASU MD 203/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication maybe shared
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: personal request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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