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

Launched by ISABELLE OPITZ, PROFESSOR, MD · Aug 28, 2020

Keywords

ClinConnect Summary

This clinical trial is comparing two different treatments for patients with severe emphysema, a lung condition that makes it hard to breathe. The study will look at how effective and safe surgical lung volume reduction surgery (which involves removing parts of the lung) is compared to a less invasive procedure called bronchoscopic lung volume reduction, which uses small valves placed in the airways to help improve lung function.

To participate in this trial, you need to be between the ages of 30 and 80 and have been diagnosed with emphysema. You should also have a body mass index (BMI) within a certain range and be a non-smoker for at least three months before joining. If you're eligible, you will undergo tests to check your lung function and overall health. Participants can expect to be closely monitored throughout the trial to ensure their safety and to gather data on how well each treatment works. This study is currently recruiting participants, so if you or someone you know might be interested, it could be a chance to explore new treatment options.

Gender

ALL

Eligibility 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