This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.
Lung volume reduction surgery (LVRS) as well as bronchoscopic lung volume reduction (BLVR) provide functional improvements in selected patients with homogenous emphysema and pronounced hyperinflation. A direct comparison of LVRS and BLVR in patients with homogenous emphysema is not available, thus the study will provide important data to guide treatment selection in this patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Surgical lung volume reduction
Bronchoscopic lung volume reduction by endobronchial valves
University Medicine Essen
Essen, North Rhine-Westphalia, Germany
RECRUITINGChange in FEV1 compared to baseline (deltaFEV1)
Percent change in FEV1
Time frame: 6 months post intervention
Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease)
Combined score including BMI, FEV1, 6 MWT, MRC dyspnoea score; range 0 (best) - 10 (worst)
Time frame: 3, 6 months post intervention
Change in TLC
Percent change in Total Lung Capacity
Time frame: 3, 6 months post intervention
Change in RV
Percent change in Residual Volume
Time frame: 3, 6 months post intervention
Change in RV/TLC
Percent change in RV/TLC ratio
Time frame: 3, 6 months post intervention
Change in DLCO
Percent change in diffusion capacity
Time frame: 3, 6 months post intervention
Change in systolic pulmonary artery pressure
measured by echocardiography
Time frame: 6 months post intervention
Changes in health-related quality of life measured by SGRQ
St. George´s Respiratory Questionnaire (score 0-100, higher scores indicating more limitations)
Time frame: 3, 6 months post intervention
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Changes in respiratory health status measured by CAT
COPD Assessment Test (CAT)
Time frame: 3, 6 months post intervention
Mortality
Number of deaths 30 days post intervention
Time frame: 30 days post intervention
Overall survival
Percent of patients alive 6 months post intervention
Time frame: 6 months post intervention
Incidence of (serious) adverse events
Number of events periprocedural, 1, 3 and 6 months post intervention
Time frame: Periprocedural, 1, 3, 6 months post intervention