Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Austria
Universitätsklinik für Thoraxchirurgie, Medical University of Vienna
RECRUITING
Vienna
Belgium
University Hospital Leuven
RECRUITING
Leuven
Denmark
Rigshospitalet, University of Copenhagen
RECRUITING
Copenhagen
Switzerland
Kantonsspital Aarau
RECRUITING
Aarau
Lausanne University Hospital (CHUV)
RECRUITING
Lausanne
University Hospital Zurich, Division of Thoracic Surgery
RECRUITING
Zurich
Contact Information
Primary
Isabelle Opitz, Prof. MD
isabelle.schmitt-opitz@usz.ch
+41 44 255 11 11
Backup
Albana Rexhepaj, PhD
Albana.RexhepajBaumann@usz.ch
+41 44 255 92 30
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2028-03
Participants
Target number of participants: 120
Treatments
Experimental: LVRS treatment group
A bilateral lung volume reduction surgery (LVRS) by video-assisted thoracoscopic surgery (VATS) is performed under general anesthesia with double lumen endobronchial intubation. Unilateral treatment is accepted in cases with severe adhesions or intraoperative instability making a bilateral procedure unsafe.
Active_comparator: BLVR study group
Unilateral bronchoscopic lung volume reduction with endobronchial valves (EBV) is performed using a flexible bronchoscope under general anesthesia and under full attendance of an anesthesiologist. Valves are placed unilaterally in segmental or subsegmental bronchi in the target lobe with the goal of complete atelectasis.
Sponsors
Leads: Isabelle Opitz, Professor, MD