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 | Recruiting

• 1 other identifier: 87RI21_0031 (REPEAT)
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 15

Brief 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

COPD

Keywords

Endobronchial Zephyr® valves; Endoscopic lung volume reduction; Pneumothorax; Emphysema; COPD

Outcome Measures

Primary Outcomes (1)

• Pneumothorax rate

  Proportion of patients suffering from at least one pneumothorax rate between the beginning and the first 45 days following the end of lung volume reduction with ZEPHYR® valves

  45 day

Secondary Outcomes (17)

• Forced expiratory volume in one second (FEV1) measurement

  0 Day, 45 Day, 6 month and 12 month

• Force Vital Expiratory (FVE) measurement

  0 Day, 45 Day, 6 month and 12 month

• Functional Residual Capacity (FRC) measurement

  0 Day, 45 Day, 6 month and 12 month

• Inspiratory Capacity (IC) measurement

  0 Day, 45 Day, 6 month and 12 month

• Residual Volume (RV) measurement

  0 Day, 45 Day, 6 month and 12 month

Study Arms (2)

two-stage ZEPHYR® valves

EXPERIMENTAL

Procedure: Endoscopic lung volume reduction in 2 stages

one-stage ZEPHYR® valves

SHAM COMPARATOR

Procedure: Endoscopic lung volume reduction in 1 stage

Interventions

Endoscopic lung volume reduction in 2 stages PROCEDURE

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)

two-stage ZEPHYR® valves

Endoscopic lung volume reduction in 1 stage PROCEDURE

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

one-stage ZEPHYR® valves

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient able to give informed consent and participate in the study
• Age ≥ 35 years old and ≤ 80 years old at the time of signing the consent
• Emphysema (homogeneous or heterogeneous) on a recent CT scan (\< 6 months). Heterogeneous emphysema defined by a difference of at least 15% destruction (threshold 910HU) between two adjacent lobes.
• Destruction ≥ 50% (threshold 910 HU) of the target lobe on the chest scanner
• Smoking quit for 3 months
• Dyspnea ≥ 2 according to the modified Medical Research Council (mMRC) questionnaire)
• Post-bronchodilator FEV between 15 and 50% theoretical
• Post-bronchodilator total lung capacity ≥ 100% theoretical and post-bronchodilator residual volume ≥ 175% theoretical
• Distance traveled during the TM6M ≥ 100m
• Member of or beneficiary of a social security scheme

You may not qualify if:

• Asthma considered as main diagnosis
• Recurrent exacerbations: (\>3 over the last year or 2 requiring hospitalization)
• Chest CT abnormalities: giant bulla (occupying more than a third of the pulmonary field), paraseptal emphysema, pulmonary nodule greater than 0.8cm (not applicable pulmonary nodules known for more than a year and stable), fibrosing interstitial pneumonitis, dilated bronchi
• Pulmonary tomoscintigraphy:
• Patients for whom the least perfused lobe is not the one with the highest emphysema destruction score
• Patients with homogeneous emphysema for whom the perfusion delta (difference in perfusion between the ipsilateral lung and the treated lobe) is less than 10%
• Arterial blood gas analysis in ambient air: Hypoxemia in ambient air (PaO2 \< 45 mmHg). Hypercapnia (PaCO2 \> 55 mmHg)
• Echocardiography:
• Left Ventricular Ejection Function \< 45%
• Systolic pulmonary arterial pressure \> 45 mmHg
• History of pneumonectomy, lung surgery homolateral to the lobe targeted for endoscopic lung volume reduction
• History of pneumothorax homolateral to the lobe targeted for endoscopic lung volume reduction
• History of endoscopic volume reduction
• Symptomatic bronchial dilatations, bronchial colonization with pseudomonas aeruginosa, multi-resistant bacteria or aspergillus origin
• Metastatic cancer undergoing treatment or whose treatments ended less than 5 years ago

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (15)

CHU de Bordeaux

Bordeaux, 33000, France

RECRUITING

CHU de Brest

Brest, 29000, France

RECRUITING

CHU de Dijon

Dijon, 21000, France

RECRUITING

chu de Grenoble

Grenoble, 38000, France

RECRUITING

CHU de Lille

Lille, 59000, France

RECRUITING

CHU de Limoges

Limoges, 87000, France

RECRUITING

APHM

Marseille, 13000, France

RECRUITING

Hopital Saint Joseph

Marseille, 13000, France

RECRUITING

CHU de Nice

Nice, 06000, France

NOT YET RECRUITING

APHP

Paris, 75018, France

RECRUITING

APHP

Paris, 78014, France

NOT YET RECRUITING

CHU de Rouen

Rouen, 76000, France

NOT YET RECRUITING

chu de Strasbourg

Strasbourg, 67000, France

RECRUITING

Hopital Foch

Suresnes, 92150, France

RECRUITING

chu de Toulouse

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pneumothorax; Emphysema

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pleural Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

Thomas EGENOD, MD

CONTACT

05 55 05 68 92; thomas.egenod@chu-limoges.fr

Eloise DOBBELS, MD

CONTACT

eloise.dobbels@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 26, 2023
• Study Start: May 6, 2024
• Primary Completion (Estimated): June 6, 2027
• Study Completion (Estimated): June 6, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15)