Informations générales (source: ClinicalTrials.gov)
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 (REPEAT)
Interventional
N/A
University Hospital, Limoges (Voir sur ClinicalTrials)
mai 2024
juin 2027
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Olivier BRUGIERE | 05/05/2025 07:12:15 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM - 13000 - Marseille - France | hervé DUTAU, MD | Contact (sur clinicalTrials) | |||
| APHP - 75018 - Paris - France | Armelle MARCEAU, MD | Contact (sur clinicalTrials) | |||
| APHP - 78014 - Paris - France | Christine LORUT, MD | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - 33000 - Bordeaux - France | Maéva ZYSMA, MD | Contact (sur clinicalTrials) | |||
| CHU de Brest - 29000 - Brest - France | Christophe GUT-GOBERT, MD | Contact (sur clinicalTrials) | |||
| CHU de Dijon - 21000 - Dijon - France | Nicolas FAVROLT, MD | Contact (sur clinicalTrials) | |||
| chu de Grenoble - 38000 - Grenoble - France | amandine BRIAULT, MD | Contact (sur clinicalTrials) | |||
| CHU de Lille - 59000 - Lille - France | Frederic WALLYN, MD | Contact (sur clinicalTrials) | |||
| CHU de Limoges - 87000 - Limoges - France | thomas EGENOD, MD | Contact (sur clinicalTrials) | |||
| CHU de Nice - 06000 - Nice - France | Jacques BOUTROS, MD | Contact (sur clinicalTrials) | |||
| CHU de Rouen - 76000 - Rouen - France | Samy LACHKAR, MD | Contact (sur clinicalTrials) | |||
| chu de Strasbourg - 67000 - Strasbourg - France | Romain KESSLER, MD | Contact (sur clinicalTrials) | |||
| chu de Toulouse - 31000 - Toulouse - France | nicolas GUIBERT, MD | Contact (sur clinicalTrials) | |||
| Hopital Saint Joseph - 13000 - Marseille - France | Yoann AMMAR, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
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
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
- Asthma considered as main diagnosis
- Recurrent exacerbations: (>3 over the last year or 2 requiring hospitalization)
- Myocardial infarction or stroke in the 6 months prior to inclusion
- Symptoms of heart failure in the 6 months prior to inclusion
- 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
- Oral corticosteroid therapy > 20 mg/day within the 4 weeks preceding inclusion
- 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
- Pregnant or breastfeeding women
- Nickel allergy
- Patient under guardianship, curatorship or under judicial protection
- Participation in another interventional clinical research
- Any other condition which, in the opinion of the investigator, could interfere with
the objective of the study or would cause the subject's participation in the study
to be suboptimal, in particular (non-exhaustive list) unweaned alcoholism, substance
abuse, non-compliance with usual follow-up visits)
secondary exclusion criteria:
- Evidence of collateral ventilation measured by the Chartis system