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Recruiting NCT06629558

Bronchoscopic Lung Volume Reduction in Management of Localized Emphysema

No phase Interventional Bronchoscopic Lung Volume Reduction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Silver Nitrate, Nano-silver nitrate, Bronchoscopic lung volume reduction.
Who it may be relevant to
Registry conditions: Bronchoscopic Lung Volume Reduction. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Chemical lung volume reduction is an endo-bronchial approach, which uses chemical agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. Endobronchial Valves (EBVs) show an overall success rate of 70-80% in reducing lung volume and improving lung function. Lung volume reduction coils (LVRC-Coils) have a success rate of 50-60%.

Bronchoscopic lung volume reduction with silver nitrate as a chemical agent was used in previous studies using a concentration of 0.5% and showed significant improvement in forced expiratory volume in first second (FEV1), diffusion capacity of lung to carbon monoxide (DLCo), modified Medical Research Council (mMRC) score when compared to base line values and reduction of the High Resolution Computed Tomography (HRCT) volumetry of the emphysematous regions.

Silver nanoparticles (AgNPs) are the most widely used nanomaterial today. These have found a wide range of applications in various areas such as textiles, agriculture, renewable energy, food, catalysis, bioremediation, and biomedicine

Interventions

  • Drug Silver Nitrate
    bronchoscopic lung volume reduction in management of localized emphysema
  • Drug Nano-silver nitrate
    bronchoscopic lung volume reduction in management of localized emphysema
  • Device Bronchoscopic lung volume reduction
    bronchoscopic lung volume reduction in management of localized emphysema

Primary outcome measures

  • Residual volume/ Total lung capacity (RV/TLC) ratio and volumetry [Time frame: 6 months]
  • change in Forced expiratory volume at first second (FEV1) and Forced vital capacity (FVC) [Time frame: 6 months]
  • Voluometry [Time frame: 6 months]
  • diffusing capacity of the lung for carbon monoxide (DLCO) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Mohamed AbdElmoniem — Al Mansurah

Identifiers

NCT: NCT06629558 · R.24.09.2776

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗