Clinical Trials in Austria / NCT04537182
Recruiting Not applicable

Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema

NCT04537182 · tracked via the Priya Life Science Austria tracker
Sponsor
Isabelle Opitz, Professor, MD
Phase
Not applicable
Started
2020-09-01
Last updated
2024-05-08

Condition(s) studied

Emphysema

Investigational drug(s) / intervention(s)

Lung volume reduction surgeryBronchoscopic lung volume reduction with valves

Lung volume reduction surgery: Lung volume reduction by surgery

Bronchoscopic lung volume reduction with valves: Lung volume reduction with endobronchial valves.

Study summary

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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients suffering from emphysema (all morphologies, uni- or bilateral distribution) potentially qualifying for both study procedures, LVRS or BLVR (if possible, perfusion scintigraphy within \< 6 month of screening, CT scan within \< 4 months of screening) * Age ≥ 30 and ≤ 80 years * Body Mass Index (BMI) ≥ 16, but ≤ 35 kg/m2 * Non-smoking for 3 months prior to screening interview * Patient is able to understand and willing to sign a written informed consent document. Exclusion Criteria: * FEV1 more than 50% predicted * TLC less than 100 % predicted, RV less than 175% predicted, RV/TLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% in heterogeneous emphysema, respectively * PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!) * PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!) * Patients with incomplete interlobar fissures as revealed by quantitative computed tomography analysis with StratX® (fissure completeness ≤ 80%) * Patients with collateral ventilation as evidenced by bronchoscopic Chartis® measurement (only performed if fissure completeness according to StratX® is \< 95%) * 6-minute walking distance ≥ 470m * More than two COPD exacerbation episodes requiring hospitalization in the last year * More than two instances of pneumonia episodes in the last year * Unplanned weight loss ≥ 10% within 90 days prior to enrollment * Pulmonary hypertension as evidenced by Delta Psyst RV-RA \> 35 mmHg on recent echocardiography (within 3 months prior to screening) and confirmed by RHC (mPAP ≥ 35 mmHg) and signs of moderate to severe RV dysfunction. * Evidence of left ventricular ejection fraction (LVEF) less than 45% on recent echocardiography (within 3 months prior to screening) * History of exercise-related syncope * Myocardial infarction or congestive heart failure within 6 months of screening * Clinically significant arrhythmias that might put the patient at risk in regard to the interventions * Prior LVR (any method), bullectomy, or lobectomy * Clinically significant bronchiectasis with expectoration of ≥ 2 tablespoons/day. * Pulmonary nodule requiring surgery * Unable to safely discontinue anticoagulants or dual antiplatelet therapy for 7 days * Patients with a life expectancy of less than one year

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Universitätsklinik für Thoraxchirurgie, Medical University of Vienna Vienna Austria Recruiting
University Hospital Leuven Leuven Belgium Recruiting
Rigshospitalet, University of Copenhagen Copenhagen Denmark Recruiting
Kantonsspital Aarau Aarau Canton of Aargau Recruiting
Lausanne University Hospital (CHUV) Lausanne Canton of Vaud Recruiting
University Hospital Zurich, Division of Thoracic Surgery Zurich Canton of Zurich Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04537182 on ClinicalTrials.gov ↗ ← All trials in Austria