Clinical Research Directory
Browse clinical research sites, groups, and studies.
Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves
Sponsor: University Hospital, Limoges
Summary
Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality. Endoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation. If this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event. A new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment. These data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.
Official title: Randomized Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves
Key Details
Gender
All
Age Range
35 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
244
Start Date
2024-05-06
Completion Date
2027-06-06
Last Updated
2025-03-18
Healthy Volunteers
No
Conditions
Interventions
Endoscopic lung volume reduction in 2 stages
After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the experimental group, patients will be treated according to Limoges' treatment algorithm (2 stages)
Endoscopic lung volume reduction in 1 stage
After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the control group, the entire lobe will be treated during one procedure
Locations (15)
CHU de Bordeaux
Bordeaux, France
CHU de Brest
Brest, France
CHU de Dijon
Dijon, France
chu de Grenoble
Grenoble, France
CHU de Lille
Lille, France
CHU de Limoges
Limoges, France
APHM
Marseille, France
Hopital Saint Joseph
Marseille, France
CHU de Nice
Nice, France
APHP
Paris, France
APHP
Paris, France
CHU de Rouen
Rouen, France
chu de Strasbourg
Strasbourg, France
Hopital Foch
Suresnes, France
chu de Toulouse
Toulouse, France