Emphysema or COPD
Conditions
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. 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.
Interventions
PROCEDURELung volume reduction surgery
Surgical lung volume reduction
PROCEDUREBronchoscopic lung volume reduction
Bronchoscopic lung volume reduction by endobronchial valves
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single center, 1:1 randomized, open label, controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FEV1 compared to baseline (deltaFEV1) | 6 months post intervention | Percent change in FEV1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in TLC | 3, 6 months post intervention | Percent change in Total Lung Capacity |
| Change in RV | 3, 6 months post intervention | Percent change in Residual Volume |
| Change in RV/TLC | 3, 6 months post intervention | Percent change in RV/TLC ratio |
| Change in DLCO | 3, 6 months post intervention | Percent change in diffusion capacity |
| Change in systolic pulmonary artery pressure | 6 months post intervention | measured by echocardiography |
| Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease) | 3, 6 months post intervention | Combined score including BMI, FEV1, 6 MWT, MRC dyspnoea score; range 0 (best) - 10 (worst) |
| Changes in respiratory health status measured by CAT | 3, 6 months post intervention | COPD Assessment Test (CAT) |
| Mortality | 30 days post intervention | Number of deaths 30 days post intervention |
| Overall survival | 6 months post intervention | Percent of patients alive 6 months post intervention |
| Incidence of (serious) adverse events | Periprocedural, 1, 3, 6 months post intervention | Number of events periprocedural, 1, 3 and 6 months post intervention |
| Changes in health-related quality of life measured by SGRQ | 3, 6 months post intervention | St. George´s Respiratory Questionnaire (score 0-100, higher scores indicating more limitations) |
Countries
Germany
Contacts
Primary ContactClemens Aigner, Prof. MD
Backup ContactKaid Darwiche, Prof. MD
Outcome results
None listed