Microbial Colonization in Lung Cancer Patients

Trial Title: Microbial Colonization in Lung Cancer Patients

NCT ID: NCT05748795

Condition: Microbial Colonization

Conditions: Official terms:
Communicable Diseases
Infections

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Procedure
Intervention name: bronchoscopy brochoalveolar lavage
Description: - 2%lidocaine gel will be used to anaesthesize nasal mucosa.6ml lidocaine 2%diluted in 5cc normal saline lidocaine spray solution will be used for anaesthesizing the vocal cords and mucosa of the bronchial tree(13). - Intravenous midazolam (0.01-0.1mg\kg) will be given to achieve conscious sedation in selected cases(13). - Flexible Bronchoscopy will be done under continuous monitoring for O2 saturation, heart rate, blood pressure and respiratory rate. - The bronchoscope will be introduced into the nasal cavity and advanced to the level of the vocal cords. Lidocaine will be instilled through the bronchoscope to the vocal cords and tracheobronchial tree. - Using sterile bronchoscope in the lobar bronchus of tumor location,100 mL of sterile normal saline in fractionated doses will be injected and then BAL will be removed by suction to be collected in sterile side-way bottles.

Summary: Primary Aim: -To determine the prevalence and pattern of bronchial colonization in patients presenting with lung cancer at the time of diagnosis Secondary Aim: -To assess the potential demographic, clinical, radiological and histological predictors of colonization in patients with lung cancer

Detailed description: Lung cancer is the world's most common neoplasm and its incidence is rising. Lung cancer has the highest mortality rates of all cancers. Pulmonary infections, especially pneumonia, frequently complicate the course of lung cancer and are often the ultimate cause of death. It has been suggested that bronchial colonization plays a key role in the establishment of pulmonary infections in patients with lung cancer, and thus clearly influences the therapeutic management and probably the prognosis of cancer. In such patients, colonization may arise following local bronchial impairment, e.g. stenosis or impaired mucociliary clearance, or be caused by more general abnormalities, including immunosuppression, malnutrition, smoking, chronic obstructive pulmonary disease (COPD) and chemotherapy. Studies indicate that bronchial colonization can be demonstrated in 48.1% of patients with lung cancer and may be caused by potential pathogenic microorganisms (PPMs), mainly Haemophilus influenzae, Streptococcus pneumoniae and Staphylococcus aureus. Other potential microbial agents, such as mycobacteria and fungi, have not been investigated systematically However, there is a wide variation in the microbial profile reported from the previous studies; some of which reporting predominance of Gram-positive organisms- streptococcus pneumoniae in particular, while more recent studies reported predominance of Gram-negative organisms, which may indicate a shift in the spectrum of organism colonizing bronchial tree of lung cancer patients in parallel to the increased trends of antibiotic exposures, something this study will re-examine. Moreover, given the paucity of literature highlighting the potential predictors of colonization in such patients, overlooking data on radiological findings in lung cancer patients and underreporting the impact of comorbidities, this study aims to further explore a wider array of potential demographic, clinical, radiological and histological determinants.

Criteria for eligibility:

Study pop:
This study will be conducted on patients who are undergoing flexible bronchoscopy for diagnosis of Lung cancer. A written consent will be obtained from all participants prior to the procedure.

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: - Age > 18 years - Radiological findings on HRCT chest suggestive of lung cancer (lung mass, pulmonary nodules with , obstructive pneumonia, unexplained lung collapse, mediastinal lymphadenopathy) Exclusion Criteria: - Patients who demonstrate clinical, laboratory or radiological evidence of active pulmonary infection that requires antibiotic therapy - Patients in whom histological evidence of lung cancer can't be proven after histopathology - Patients deemed unfit for bronchoscopy - Uncorrected hypoxia under oxygen spo2 <90% - Uncontrolled cardiac arrhythmias despite medical treatment and arrhythmias associated with haemodynamic compromise . - patient who has risk factors for abnormal coagulation - Undrained Pneumothorax - Asthma and Chronic obstructive pulmonary disease who had suffered exacerbation during the preceding 3 weeks - Myocardial infarction in the previous 4 weeks

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Tasneem Hassan Younes

Address:
City: Assiut
Zip: 29601288800041
Country: Egypt

Status: Recruiting

Contact:
Last name: Olfat M Elshenawy, professor

Phone: 01005602285
Email: dr_olfat_mostafa@yahoo.com

Contact backup:
Last name: Mohamed M Abdelhady, professor

Phone: 01223971614
Email: Melhadi@yahoo.com

Investigator:
Last name: Hebatallah G Rashed, professor
Email: Principal Investigator

Start date: February 1, 2023

Completion date: February 1, 2024

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05748795