Comparing lung surgery and bronchoscopic treatment for severe emphysema
Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial
This study is testing whether lung surgery or a less invasive bronchoscopic treatment works better for people with severe emphysema.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 6 sites (Vienna and 5 other locations) |
| Trial ID | NCT04537182 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness and safety of bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in patients suffering from severe emphysema. The study will involve a randomized controlled design to assess outcomes related to both interventions. By evaluating patients who qualify for either procedure, the trial seeks to provide valuable insights into the optimal management of emphysema. The findings are expected to contribute significantly to the understanding of treatment options for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 30 to 80 with severe emphysema who qualify for either LVRS or BLVR.
Not a fit: Patients with mild emphysema or those who do not meet the specific pulmonary function criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with severe emphysema, enhancing their quality of life.
How similar studies have performed: While there have been positive reports on both surgical and bronchoscopic volume reduction, this study is novel in directly comparing the two approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vienna and 5 other locations
- 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, Switzerland (Recruiting)
- Lausanne University Hospital (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)
- University Hospital Zurich, Division of Thoracic Surgery — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Isabelle Opitz, Prof. MD — University of Zurich
- Study coordinator: Isabelle Opitz, Prof. MD
- Email: isabelle.schmitt-opitz@usz.ch
- Phone: +41 44 255 11 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.