LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial
LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial
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.
Inclusion Criteria:

 -  COPD III-IV

 -  Age ≥ 18 years

 -  FEV1 < 50% predicted after bronchodilatation

 -  Significant hyperinflation (TLC >100% predicted, RV > 200% predicted, RV/TLC > 60%)

 -  Non-smoker or ex-smoker for > 3 months (documented by cotinine testing)

 -  6 MWT >150 m and ≤ 450m

 -  MRC dyspnea score > 3

 -  Homogenous emphysema as assessed by HR-CT (< 15% difference in emphysema destruction
 score between target lobe and ipsilateral lobe) [16, 17]

 -  Uni- or bilateral collateral ventilation (CV) negative result assessed fissure
 completeness>95% in QCT and confirmed by a bronchoscopic procedure (Chartis©)

 -  Optimal medical therapy for > 3months, sufficient rehabilitation status with no need
 for further training/rehabilitation or rehabilitation within 6 months prior to
 intervention.

 -  Body Mass Index (BMI) > 18, but < 35 kg/m2

 -  Daily dose of prednisone ≤ 10mg

 Exclusion Criteria:

 -  Contraindication against either LVRS or BLVR and/or to surgery and bronchoscopy in
 general

 -  Major comorbidities limiting survival

 -  Age ≥ 80 years

 -  Nicotine abuse within 3 months (documented by cotinine testing)

 -  Predominance of either left or right lung of >70% in perfusion SPECT scintigraphy

 -  FEV1 and/or DLCO <20% predicted (post bronchodilatation)

 -  Untreated Hypoxemia (PaO2 < 50 mmHg)

 -  Untreated Hypercapnia (PaCO2 > 50 mmHg)

 -  Significant pulmonary fibrosis or bronchiectasis

 -  Destroyed/vanished lung on HR-CT

 -  Previous chest surgery or bronchoscopic interventions

 -  Pulmonary hypertension (sPAP > 35 mmHg)

 -  Active waiting list for lung transplantation

 -  Patient is not able to understand and willing to sign a written informed consent
 document.

 -  Pregnancy