Actively Recruiting
Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema
Led by Isabelle Opitz, Professor, MD · Updated on 2024-05-08
120
Participants Needed
6
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with emphysema (all types and distributions) suitable for both lung volume reduction surgery or bronchoscopic lung volume reduction
- Age between 30 and 80 years
- Body mass index (BMI) between 16 and 35 kg/m2
- Non-smoker for at least 3 months before screening
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Forced expiratory volume in 1 second (FEV1) more than 50% predicted
- Total lung capacity (TLC) less than 100% predicted
- Residual volume (RV) less than 175% predicted
- RV/TLC ratio less than 58% predicted
- Diffusing capacity for carbon monoxide (DLCO) 20% or less in homogeneous emphysema or 15% or less in heterogeneous emphysema
- Low oxygen level (PaO2 ≤ 6.0 kPa) in homogeneous emphysema
- High carbon dioxide level (PaCO2 ≥ 6.6 kPa) in homogeneous emphysema
- Incomplete interlobar fissures with less than 80% completeness
- Presence of collateral ventilation if fissure completeness is less than 95%
- 6-minute walking distance 470 meters or more
- More than two COPD exacerbations requiring hospitalization in the last year
- More than two pneumonia episodes in the last year
- Unplanned weight loss of 10% or more within 90 days prior to enrollment
- Pulmonary hypertension with specific echocardiography and right heart catheterization findings
- Left ventricular ejection fraction below 45%
- History of exercise-related fainting
- Myocardial infarction or congestive heart failure within 6 months prior to screening
- Significant arrhythmias posing risk for interventions
- Previous lung volume reduction, bullectomy, or lobectomy
- Significant bronchiectasis with daily expectoration of 2 tablespoons or more
- Pulmonary nodule requiring surgery
- Unable to safely stop anticoagulants or dual antiplatelet therapy for 7 days
- Life expectancy less than one year
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Universitätsklinik für Thoraxchirurgie, Medical University of Vienna
Vienna, Austria
Actively Recruiting
2
University Hospital Leuven
Leuven, Belgium, 3000
Actively Recruiting
3
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100
Actively Recruiting
4
Kantonsspital Aarau
Aarau, Canton of Aargau, Switzerland, 5001
Actively Recruiting
5
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
6
University Hospital Zurich, Division of Thoracic Surgery
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
I
Isabelle Opitz, Prof. MD
CONTACT
A
Albana Rexhepaj, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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