Stenoses, Dyspnea
Conditions
Keywords
Non-malignant Airway stenoses, Endoscopic Treatment, 3D customized stent, stent
Brief summary
The placement of an endoprosthesis in the airways leads to rapid and dramatic clinical improvement in the majority of cases of central airway obstruction. However, the limited diversity of device shapes available on the market is a major limitation, as these devices are poorly adapted, or not adapted at all, to the patient's anatomy. The main consequences of this lack of congruity are stent migration and granulomatous inflammatory reactions. The investigators hypothesized that personalized endoprostheses could significantly reduce the complication rate and improve tolerability. In this randomized controlled trial, the investigators propose to evaluate whether personalized endoprostheses allow for better management of non-malignant central airway stenoses by comparing this new approach to standard care.
Interventions
OTHERInformed consent
During the pre-inclusion/inclusion visit, the investigator informs the participant and answers all questions regarding the purpose, nature of the constraints, foreseeable risks and the expected benefits of the clinical investigation. The investigating physician then provides the participant with a copy of the information note and informed consent form. After this information session, the participant is granted a reflection period. If the participant agrees to participate
OTHEREligibility criteria check
The investigator also specifies the participant's rights in the context of research and checks the eligibility criteria.
OTHERRandomisation
When an investigator wishes to perform the randomisation after checking the eligibility criteria and consent of the participant, he/she will connect to the dedicated Clinsight Website.
BEHAVIORALDyspnea-12 questionnaire
The DYSPNEA-12 questionnaire helps to understand how shortness of breath impacts a patient's life. This questionnaire contains 12 questions that assess the physical and emotional aspects of dyspnea in daily life by checking one of the following boxes: not at all, slightly, moderately, severely
BEHAVIORALVQ11 questionnaire
The VQ11 questionnaire is a quality of life questionnaire. It contains 11 statements that express feelings about the consequences of a respiratory illness. For each statement, the patient must check the intensity that corresponds to their experience from among: not at all, a little, moderately, a lot, and extremely.
BEHAVIORALEQ-5D-5L questionnaire
This questionnaire assesses the patient's mobility, autonomy, activities, pain, and anxiety using 5 items. For each item, the patient must select the situation that best describes them from among 5 options: no problem, mild problems, moderate problems, severe problems, or unable to function.
OTHERSpirometry
non-invasive measurement of ventilatory function, including peak expiratory flow and forced expiratory volume in 1 second (FEV1)
RADIATIONChest CT scan
High resolution chest CT scan without injection of contrast medium. The scanner required for the manufacture of the prosthesis must be a high-resolution CT scanner, the recommendations for which are specified in the order file for a 3D stent
PROCEDURECommercially Stent Implantation
During the commercially stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse.
PROCEDUREExperimental Stent Implantation
During the experimental stent implantation, a video of the procedure will be recorded and all the pseudonymized videos of each center will be centralized and stored in the pulmonology department of Pr Nicolas Guibert of CHU of Toulouse.
Sponsors
University Hospital, Toulouse
novatech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years, * Central non-malignant symptomatic (dyspnea \> grade 2 mMRC or post-stenotic infection) airway stenosis with silicone stent implantation indication (viable downstream airways, pulmonary artery and parenchyma), * To have access to a personal telephone for the teleconsultation scheduled in the protocol, * Informed consent signed, * Health insurance beneficiary.
Exclusion criteria
* Acute respiratory distress, * Mechanical ventilation, * Contraindication to rigid bronchoscopy: severe coagulation disorders that cannot be corrected, anticoagulant or antiplatelet therapy other than aspirin within 5 days prior to the stent implantation, * Malignant stenosis, * Pregnancy or breast-feeding, * A situation in which emergency or semi-emergency intervention (less than 48 hours) may be anticipated (like an acute respiratory distress for example), * Patient under legal protection, - Participation in another study with an exclusion period still in progress, * Impossibility of giving the person informed information and of ensuring the subject's compliance due to impaired physical and/or psychological health.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s) | 47 months | Rate of patients (Cox model) experiencing one or more severe stent and/or procedure-related complication(s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate (percent) of all adverse events | 15 months | Rate (percent) of all adverse events at 3, 6 and 12 months, specifying the causal relationship with the procedure and the MD (certain, probable, possible, not-related) and the intensity (grade). |
| Evolution in dyspnea | 15 months | Evolution in dyspnea by mMRC from baseline to 3, 6 and 12 months of follow-up using a Student's t-test. The mMRC (MODIFIED MEDICAL RESEARCH COUNCIL) is a scale for assessing dyspnea. There are five stages of dyspnea, numbered from 0 to 4, with 4 being the stage where shortness of breath is most severe. |
| Evolution of quality of life | 15 months | Evolution of quality of life by VQ11 questionnaire from baseline to 3, 6 and 12 months of follow-up using a Student's t-test. The VQ11 questionnaire is a quality of life questionnaire. It contains 11 statements that express feelings about the consequences of a respiratory illness. For each statement, the patient must check the intensity that corresponds to their experience from among: not at all, a little, moderately, a lot, and extremely. |
| Change in pulmonary function tests | 15 months | Change in pulmonary function tests by pulmonary function tests from baseline to 3 and 12 months using a Student's t-test |
Countries
France
Contacts
CONTACTAudrey TOMASIK
Outcome results
None listed