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This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.
Lung volume reduction surgery (LVRS) as well as bronchoscopic lung volume reduction (BLVR) provide functional improvements in selected patients with homogenous emphysema and pronounced hyperinflation. A direct comparison of LVRS and BLVR in patients with homogenous emphysema is not available, thus the study will provide important data to guide treatment selection in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung volume reduction surgery arm | Active Comparator | Bilateral videothoracoscopic lung volume reduction surgery by wedge resection. Unilateral procedures are possible in case of severe adhesions or intraoperative instability. In these cases a staged approach with contralateral LVRS within 3 months is possible. |
|
| Bronchoscopic lung volume reduction arm | Active Comparator | Primarily unilateral bronchoscopic lung volume reduction by endobronchial valves. If a bilateral procedure is feasible it must be performed within 3 months after the first intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung volume reduction surgery | Procedure | Surgical lung volume reduction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 compared to baseline (deltaFEV1) | Percent change in FEV1 | 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease) | Combined score including BMI, FEV1, 6 MWT, MRC dyspnoea score; range 0 (best) - 10 (worst) | 3, 6 months post intervention |
| Change in TLC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clemens Aigner, Prof. MD | Contact | +49201433 | 4011 | clemens.aigner@rlk.uk-essen.de |
| Kaid Darwiche, Prof. MD | Contact | +49201433 | 4222 | kaid.darwiche@rlk.uk-essen.de |
| Name | Affiliation | Role |
|---|---|---|
| Clemens Aigner, Prof. MD | UniversitƤt Duisburg-Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medicine Essen | Recruiting | Essen | North Rhine-Westphalia | 45239 | Germany |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D011013 | Pneumonectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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single center, 1:1 randomized, open label, controlled
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| Bronchoscopic lung volume reduction | Procedure | Bronchoscopic lung volume reduction by endobronchial valves |
|
Percent change in Total Lung Capacity |
| 3, 6 months post intervention |
| Change in RV | Percent change in Residual Volume | 3, 6 months post intervention |
| Change in RV/TLC | Percent change in RV/TLC ratio | 3, 6 months post intervention |
| Change in DLCO | Percent change in diffusion capacity | 3, 6 months post intervention |
| Change in systolic pulmonary artery pressure | measured by echocardiography | 6 months post intervention |
| Changes in health-related quality of life measured by SGRQ | St. GeorgeĀ“s Respiratory Questionnaire (score 0-100, higher scores indicating more limitations) | 3, 6 months post intervention |
| Changes in respiratory health status measured by CAT | COPD Assessment Test (CAT) | 3, 6 months post intervention |
| Mortality | Number of deaths 30 days post intervention | 30 days post intervention |
| Overall survival | Percent of patients alive 6 months post intervention | 6 months post intervention |
| Incidence of (serious) adverse events | Number of events periprocedural, 1, 3 and 6 months post intervention | Periprocedural, 1, 3, 6 months post intervention |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |