Status:
UNKNOWN
LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial
Lead Sponsor:
Universität Duisburg-Essen
Conditions:
Emphysema or COPD
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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.
Detailed 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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04781582
Start Date
June 8 2021
End Date
November 1 2024
Last Update
September 28 2021
Active Locations (1)
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1
University Medicine Essen
Essen, North Rhine-Westphalia, Germany, 45239