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

ConditionEmphysema

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age30-80

SponsorIsabelle Opitz, Professor, MD

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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!)

Trial design

Treatments tested in this trial

Lung volume reduction surgery
Bronchoscopic lung volume reduction with valves

Treatment groups

120 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Isabelle Opitz, Professor, MD

Lead sponsor

University of Zurich

Sponsor institution

Source ClinicalTrials.gov