Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Multi-Center, Prospective, Clinical Trial Designed to Study the Efficacy of One-Way Valve Implantation Based on a New Treatment Algorithm in Patients With Heterogeneous Emphysema
The purpose of this study is to assess the efficacy of a new treatment algorithm for bronchoscopic lung volume reduction (BLVR) in patients with emphysema based on the information of emphysema heterogeneity, destruction score, and fissure analysis.
Emphysema is a progressive pulmonary disease characterized by abnormal and permanent
enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of
pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation
and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit
from surgical lung volume reduction and/or lung transplantation. The rationale for lung
volume reduction surgery is that reducing lung size would restore elastic recoil of the lung
and improve chest wall and diaphragm mechanics. It has previously been shown that
particularly patients with heterogeneous emphysema seem to benefit most from surgical lung
volume reduction.
Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive
potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects
of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively
occlude the airways supplying the most affected hyperinflated regions of the emphysematous
lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar
volume reduction, simulating the effects of surgical LVR. Recent trials of BLVR using
endobronchial one-way valves demonstrated significant improvements in lung function
parameters, exercise capacity and quality of life in patients with end-stage emphysema. The
treatment algorithm for valve implantations to achieve BLVR, however, varied considerably in
these reports as well as clinical and functional response rates. Subset analysis of these
studies revealed that particularly, but not exclusively, patients with radiological signs of
lung volume reduction treated unilaterally showed significant clinical improvements, whereas
most patients without signs of lung volume reduction did not experience these benefits. The
present study investigates the response to BLVR based on a new treatment algorithm including
lung function criteria and computed tomography of the thorax.
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