RecruitingNot ApplicableNCT06629558

Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema

Efficacy and Safety of 0.5% w/v Nano- Silver Nitrate Versus Silver Nitrate Solution for Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema: Prospective Interventional Randomized Controlled Clinical Trial


Sponsor

Mansoura University Hospital

Enrollment

30 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Emphysema is a progressive phenotype of chronic Obstructive Pulmonary Disease (COPD), poses a significant global health burden characterized by irreversible lung parenchymal destruction and airspace enlargement. In recent years, bronchoscopic lung volume reduction (BLVR) has considerable interest as a minimally invasive approach to reducing hyperinflation and improving lung function in patients with emphysema. BLVR techniques aim to achieve lung volume reduction by occluding or ablating emphysematous lung tissue through endobronchial delivery of various agents. Many techniques are available for BLVR as coil, endo-bronchial valve, and biological as thrombin, autologous blood and chemicals as silver nitrate solution.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria1

  • COPD of grade III and IV according to GOLD 2024 staging of COPD with localized (heterogeneous) emphysema as determined by high resolution computerized tomography (HRCT) of the chest with area of destruction >-950 Hounsfield units (HU) and respiratory symptoms despite optimal medical therapy with the following criteria: Patient less than 75 years of age not candidate for or had refused lung volume reduction surgery but fit for fibro-optic bronchoscope (FOB). Lung volumes criteria: FEV1 less than 60% of predicted value, Residual volume (RV) more than 100% of predicted value, Total lung capacity (TLC) more than 100% of predicted value, 6 MWT of less than 450 meters.

Exclusion Criteria7

  • Significant co-morbidities that limits exercise capacity or prognosis as cardiovascular diseases (heart failure, arrhythmia, ischemic heart disease) and lung cancer.
  • Patients unfit or refused FOB.
  • Homogenous emphysema.
  • More than 75 years of age.
  • Associated lung fibrosis.
  • FEV1 > 60%.
  • Current smoker.

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Interventions

DRUGSilver Nitrate

bronchoscopic lung volume reduction in management of localized emphysema

DRUGNano-silver nitrate

bronchoscopic lung volume reduction in management of localized emphysema

DEVICEBronchoscopic lung volume reduction

bronchoscopic lung volume reduction in management of localized emphysema


Locations(1)

Mohamed AbdElmoniem

Al Mansurah, Egypt

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NCT06629558