LVRS Versus BLVR in Patients With Homogenous Emphysema CLUB-HE Trial

  • STATUS
    Recruiting
  • End date
    Nov 3, 2024
  • participants needed
    62
  • sponsor
    Universität Duisburg-Essen
Updated on 3 October 2021

Summary

This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.

Description

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.

Details
Condition Emphysema or COPD
Treatment Lung volume reduction surgery, Bronchoscopic lung volume reduction, Bronchoscopic lung volume reduction
Clinical Study IdentifierNCT04781582
SponsorUniversität Duisburg-Essen
Last Modified on3 October 2021

Eligibility

Yes No Not Sure

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)
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
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