The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.
Advanced lung emphysema has a considerable impact on quality of life in patients with chronic obstructive pulmonary disease. There are positive reports of surgical as well as bronchoscopic volume reduction in selected patients, but data comparing LVRS and BLVR is unfortunately lacking to date. The investigators therefore anticipate that their study will make an important contribution to the worldwide efforts in better understanding selection and management of surgical and bronchoscopic treatment of emphysema patients and that it will be of high public interest.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Lung volume reduction by surgery
Lung volume reduction with endobronchial valves.
Universitätsklinik für Thoraxchirurgie, Medical University of Vienna
Vienna, Austria
RECRUITINGUniversity Hospital Leuven
Leuven, Belgium
RECRUITINGRigshospitalet, University of Copenhagen
Copenhagen, Denmark
Change from baseline value in FEV1 (ml)
Percent change in FEV1
Time frame: 6 months after intervention
Change from baseline value in FEV1
Percent change in forced expiratory volume (FEV1)
Time frame: 3 and 12 months after intervention
Change from baseline value in RV
Percent change in residual volume (RV)
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in TLC
Percent change in total lung capacity (TLC)
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in RV/TLC
Percent change in RV-to-TLC ratio
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in DLCO
Percent change in diffusion capacity (DLCO)
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in 6-minute walking distance
Distance that can be walked within 6 minutes
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in mMRC dyspnea score
Degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4
Time frame: 3, 6 and 12 months after intervention
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Kantonsspital Aarau
Aarau, Canton of Aargau, Switzerland
RECRUITINGLausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, Switzerland
RECRUITINGUniversity Hospital Zurich, Division of Thoracic Surgery
Zurich, Canton of Zurich, Switzerland
RECRUITINGChange from baseline in quality of life (SGRQ, EQ-5D-5L)
St. George's Respiratory Questionnaire to assess quality of life
Time frame: 3, 6 and 12 months after intervention
Change from baseline regarding pain (PDI score)
Pain Disability Index score
Time frame: 3, 6 and 12 months after intervention
Change from baseline regarding pain (VAS)
Pain assessment with visual analog scale (VAS)
Time frame: 3, 6 and 12 months after intervention
Incidence of (serious) adverse events / re-interventions
Number and degree of adverse events after intervention
Time frame: 3, 6 and 12 months after intervention
30-days mortality
Number of deaths (all causes) 1 month after intervention
Time frame: 1 month
90-days mortality
Number of deaths (all causes) 3 months after intervention
Time frame: 3 months
Overall survival rate
Percentage of patients alive 1 year after intervention
Time frame: 12 months