Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema Clinical Trial
Official title:
Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests.
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.
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves
(Zephyr) would reduce native lung overinflation in patients that underwent single lung
transplantation due to emphysema, and improve their well being and pulmonary function tests
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment