Comparing lung surgery and bronchoscopic treatment for severe emphysema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Xenon MRI test for lung changes after Apreo BREATHE airway treatment in emphysema

  This study tests whether hyperpolarized Xenon MRI can show regional ventilation and gas-exchange changes after the Apreo BREATHE airway scaffolds in people with emphysema and air trapping.

  Recruiting Early Phase 1 Apreo Health, Inc. · Birmingham, Alabama and 1 other locations · NCT07896902

• Prediction score for death or lung transplant in emphysema caused by alpha-1 antitrypsin deficiency

  This study tests a new prediction tool to identify people with emphysema due to alpha-1-antitrypsin deficiency who are at high risk of death or needing a lung transplant.

  Recruiting at 4 sites University Hospital, Bordeaux · Bron and 3 other locations · NCT07715617

• Testing CE1226 doses to slow lung disease in adults with alpha-1 antitrypsin deficiency

  This trial tests two active doses of CE1226 to see if they slow lung density decline in adults with AAT deficiency and emphysema over 3 years compared with the standard 60 mg/kg dose.

  Recruiting at 2 sites Phase 4 CSL Behring · Aalborg and 1 other locations · NCT07326592

• Implant to help adults with severe emphysema

  This study will test whether an implantable artificial bronchus can improve breathing and safety in adults with severe COPD/emphysema.

  Recruiting at 4 sites Pulmair Medical, Inc. · San Francisco, California and 3 other locations · NCT07119229

• Endobronchial silicone valve to help breathing in people with severe emphysema

  This trial tests whether placing a silicone valve in the airways of one lung region can improve breathing for people with severe emphysema when added to usual care.

  Recruiting China-Japan Friendship Hospital · Beijing, Beijing Municipality · NCT07097896

• Implantable Artificial Bronchus 50 Flex for adults with severe emphysema

  This tests a small implant called the IAB 50 Flex to see if it is safe and helps adults with severe COPD or emphysema breathe and move more easily.

  Recruiting at 2 sites Pulmair Medical, Inc. · Limoges and 1 other locations · NCT07086339

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.