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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

NCT06181357 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

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)

PROCEDURE

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

Sponsors & Collaborators

  • University Hospital, Limoges

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2027-06-06
Completion
2027-06-06

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06181357 on ClinicalTrials.gov