Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Advanced lung emphysema has a considerable impact on quality of life in patients with chronic obstructive pulmonary disease. There are positive reports of surgical as well as bronchoscopic volume reduction in selected patients, but data comparing LVRS and BLVR is unfortunately lacking to date. The investigators therefore anticipate that their study will make an important contribution to the worldwide efforts in better understanding selection and management of surgical and bronchoscopic treatment of emphysema patients and that it will be of high public interest.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVRS treatment group | Experimental | 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. |
|
| BLVR study group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung volume reduction surgery | Procedure | Lung volume reduction by surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline value in FEV1 (ml) | Percent change in FEV1 | 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline value in FEV1 | Percent change in forced expiratory volume (FEV1) | 3 and 12 months after intervention |
| Change from baseline value in RV | Percent change in residual volume (RV) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Opitz, Prof. MD | Contact | +41 44 255 11 11 | isabelle.schmitt-opitz@usz.ch | |
| Albana Rexhepaj, PhD | Contact | +41 44 255 92 30 | Albana.RexhepajBaumann@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle Opitz, Prof. MD | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Thoraxchirurgie, Medical University of Vienna | Recruiting | Vienna | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011013 | Pneumonectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
Not provided
Not provided
International, multi-center, open label, morphology- and site-stratified, 1:1 randomized, actively controlled
Not provided
Not provided
Not provided
Not provided
| Bronchoscopic lung volume reduction with valves | Procedure | Lung volume reduction with endobronchial valves. |
|
|
| 3, 6 and 12 months after intervention |
| Change from baseline value in TLC | Percent change in total lung capacity (TLC) | 3, 6 and 12 months after intervention |
| Change from baseline value in RV/TLC | Percent change in RV-to-TLC ratio | 3, 6 and 12 months after intervention |
| Change from baseline value in DLCO | Percent change in diffusion capacity (DLCO) | 3, 6 and 12 months after intervention |
| Change from baseline value in 6-minute walking distance | Distance that can be walked within 6 minutes | 3, 6 and 12 months after intervention |
| Change from baseline value in mMRC dyspnea score | Degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 | 3, 6 and 12 months after intervention |
| Change from baseline in quality of life (SGRQ, EQ-5D-5L) | St. George's Respiratory Questionnaire to assess quality of life | 3, 6 and 12 months after intervention |
| Change from baseline regarding pain (PDI score) | Pain Disability Index score | 3, 6 and 12 months after intervention |
| Change from baseline regarding pain (VAS) | Pain assessment with visual analog scale (VAS) | 3, 6 and 12 months after intervention |
| Incidence of (serious) adverse events / re-interventions | Number and degree of adverse events after intervention | 3, 6 and 12 months after intervention |
| 30-days mortality | Number of deaths (all causes) 1 month after intervention | 1 month |
| 90-days mortality | Number of deaths (all causes) 3 months after intervention | 3 months |
| Overall survival rate | Percentage of patients alive 1 year after intervention | 12 months |
| University Hospital Leuven | Recruiting | Leuven | 3000 | Belgium |
|
| Rigshospitalet, University of Copenhagen | Recruiting | Copenhagen | 2100 | Denmark |
|
| Kantonsspital Aarau | Recruiting | Aarau | Canton of Aargau | 5001 | Switzerland |
|
| Lausanne University Hospital (CHUV) | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
|
| University Hospital Zurich, Division of Thoracic Surgery | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
|