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This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves
The primary objective of the current study is to explore the effect of targeted lobar endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent collateral ventilation, on lung function, exercise capacity and physical activity. As a secondary objective, changes in physical activity as result of a 3 month activity coaching program delivered between 3 to 6 months post intervention will be investigated. Exploratory objectives are to extend insight in the clinical characteristics of responders and non-responders and to address relationships between lung function response, physical functioning and its impact on inflammation, skeletal and cardiac function. Furthermore, comparison of the effects on lung function, exercise capacity, quality of life and physical activity between endoscopic lung volume reduction and surgical lung volume reduction will be made.
The study will also explore if treatment response can be optimised by an intermediate evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning of the endobronchial valves will be imposed in case no lober atelectasis is visualised.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Other | standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation. |
|
| Endobronchial valves | Experimental | Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endobronchial valves | Device | A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side. |
| Measure | Description | Time Frame |
|---|---|---|
| response rate of FEV1 at 3 months post intervention | proportion of patients with a minimal change of FEV1 > 100 ml | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| response rate on SGRQ at 3 months and 6 months post intervention | proportion of patients with a minimal change of -4 points on SGRQ | 3 months and 6 months post intervention |
| response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post intervention | Absolute difference from baseline values (liters) | 3 months and 6 months post intervention |
| Change in RV/TLC ratio (%) at 3 and 6 months post intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Denaux, sc, nurse | Contact | 016 34 19 66 | 0032 | karen.denaux@uzleuven.be |
| Kristien De Bent, sc | Contact | 016 34 17 01 | 0032 | krisiten.debent@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Wim Janssens, MD | University hospital Leuven, Belgium | Principal Investigator |
| Dooms Christophe, MD | University Hospial Leuven, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | Flanders | 3000 | Belgium |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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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| physical activity tele coaching | Behavioral | 3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback. |
|
| Lung volume reduction surgery (LVRS) | Procedure | Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed. |
|
proportion of patients with a minimal improvement of 30 meters on 6MWD |
| 3 months and 6 months post intervention |
| response rate on residual volume (RV) at 3 months and 6 months post intervention | proportion of patients with a minimal reduction of 400 ml on residual volume | 3 months and 6 months post intervention |
| response rate on FEV1 at 6 months post intervention | proportion of patients with a minimal change of FEV1 > 100 ml | 6 months |
| response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention | proportion of patients with a minimal change of -1 point on TDI | 3 months and 6 months post intervention |
Absolute difference from baseline values (%)
| 3 months and 6 months post intervention |
| Change in 6MWD (meters) at 3 and 6 months post intervention | Absolute difference from baseline values (meters) | 3 months and 6 months post intervention |
| Change in physical activity at 3 months post intervention | Absolute difference in stepcounts per day (n) from baseline values | 3 months post intervention |
| Change in ProActive clinical visit questionnaire | Absolute difference in points from baseline values | 3 months post intervention |
| Change in BODE index | Absolute difference in points from baseline values | 3 months and 6 months post intervention |
| changes in physical activity between 3 and 6 months of follow up (telecoaching period) | Absolute difference in stepcounts per day (n) 3 months - 6 months post allocation | 3 months - 6 months post allocation |
| changes in ProActive clinical visit questionnaire between 3 and 6 months of follow up (telecoaching period) | Absolute difference in points 3 months - 6 months post allocation | 3 months - 6 months post allocation |
| Comparing change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post EBV and LVRS | Absolute difference from baseline values (liters) for both interventions | 3 months and 6 months post intervention (endoscopic or surgical) |
| Comparing change in 6MWD at 3 and 6 months post EBV and LVRS | Absolute difference from baseline values (meters) for both interventions | 3 months and 6 months post intervention (endoscopic or surgical) |
| Comparing change in physical activity at 3 and 6 months post EBV and LVRS | Absolute difference from baseline values (amount of steps per day) for both interventions | 3 months and 6 months post intervention (endoscopic or surgical) |
| Comparing change in SGRQ at 3 and 6 months post EBV and LVRS | Absolute difference from baseline values for both interventions | 3 months and 6 months post intervention (endoscopic or surgical) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |