Lung Volume Reduction Coil Treatment in Emphysema. (STICREVOLENS)
|ClinicalTrials.gov Identifier: NCT01822795|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2013
Last Update Posted : April 30, 2014
- BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
- METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
- EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.
|Condition or disease||Intervention/treatment||Phase|
|Emphysema||Procedure: Lung volume reduction coïl treatment Other: Regular medical treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||December 2019|
Experimental: Lung volume reduction coïl treatment
Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention
|Procedure: Lung volume reduction coïl treatment Other: Regular medical treatment|
Regular Medical Treatment
No intervention, just a follow up under usual medical treatment
|Other: Regular medical treatment|
- 6-month improvement of the 6-minute walk test [ Time Frame: 6 months ]6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.
- Cost-effectiveness [ Time Frame: 6 and 12 months ]Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.
- Dyspnea [ Time Frame: 6 and 12 months ]Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale
- Pulmonary function assessment [ Time Frame: 6 and 12 months ]Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.
- Quality of life [ Time Frame: 6 and 12 months ]Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)
- Morbidity-mortality [ Time Frame: 6 and 12 months ]Comparison of mortality and severe adverse events using a composite score (death, haemoptysis > 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage > 7 days, mechanical ventilation > 24 hours, lung transplantation).
- Exercise testing [ Time Frame: 6 and 12 months months ]Comparison of the 6-min walking test between groups (using the > 25 meters change from baseline as cut-off for clinically significant change).
- Exercise testing [ Time Frame: 12 months ]Comparison of the 6-min walking distance at 12 months using 54 meters as cut-off for clinically significant change.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822795
|AMIENS Cedex 1, France, 80054|
|CHU de Grenoble|
|GRENOBLE Cedex 9, France, 38043|
|Marseille, France, 13015|
|CHU de Montpellier|
|MONTPELLIER Cedex 5, France, 34295|
|CHU de Nice|
|Nice, France, 06002|
|AP-HP - Hôpital Bichat|
|PARIS Cedex 18, France, 75877|
|CHU de Rouen|
|ROUEN Cedex, France, 76031|
|CHU de Saint-Etienne|
|Saint-priest-en-jarez, France, 42270|
|Hôpitaux Universitaires de Strasbourg|
|STRASBOURG Cedex, France, 67091|
|Principal Investigator:||Gaëtan DESLEE, PhD, MD||CHU de Reims|