Airway Disease
Conditions
Keywords
rigid bronchoscopy, 3D computer-assisted fabrication, silicon-dedicated stent
Brief summary
Airway stenting is usually efficient to treat central airway obstruction but can lead to severe and potentially lethal complications (stent migration, obstructive granuloma, perforation, and hemoptysis). 3D customized airway stents (computer-aided conception using CT-scan data), perfectly suited to airway anatomy, should improve the tolerance and safety of airway stenting. We demonstrated in a previous pilot study, dedicated to patients with anatomically complex stenoses the safety of 3D patient-specific stents. These appealing results in highly complex situations suggest the need to evaluate these devices in more common situations. In this study we aim to test our new generation stents in all patients planned for airway stenting. After computer-assisted segmentation of airways (VGStudioMAX 3.0 software), the stenosis is virtually corrected, leading to the conception of a virtual stent (AnatomikModeling, Toulouse), allowing for the fabrication of a mold using a 3D printer. The stent is then built and sterilized (NOVATECH, Berlin) and inserted during rigid bronchoscopy. Close follow up is then conducted, including clinical evaluation after one week, three, six and 12 months; spirometry at one week, 3 months, 6 months and 12 months and chest CT-scan at one week.
Interventions
DEVICECustom-designed tracheobronchial prostheses
Computer-assisted segmentation of airways and stent from CT data (AnatomikModeling) Fabrication of a mold and then a silicon stent by mold injection and sterilization (NOVATECH) Insertion of the stent under rigid bronchoscopy and general anesthesia
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Informed consent * Complex, proximal and symptomatic (dyspnea, cough, peak flow \< 50%, FEV1 \< 50% or post-stenotic infection) airway stenosis
Exclusion criteria
* Acute respiratory distress, mechanical ventilation * Contraindication to rigid bronchoscopy (severe and irreversible coagulation disorders) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of procedures with clinical improvement of the dyspnea | 12 months | Percentage of procedures with clinical improvement of the dyspnea with questionnaires of Borg, modified Medical Research Council (mMRC), and Dyspnea 12 |
| Percentage of procedures with clinical improvement of quality of life | 12 months | Percentage of procedures with clinical improvement of quality of life with the VQ11 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of procedures with functional improvement | 1 seconde | Percentage of procedures with functional improvement ( forced expiratory volume in one second (FEV1)) |
| Percentage of procedures with congruence of the stent | 1 week | Percentage of procedures with congruence of the stent with tracheobronchial anatomy on CT-scan at 1 week |
| Percentage of procedures without complications | 12 months | Percentage of procedures without complications at 1 week, 3 months, 6 months and 12 months (stent migration, obstructive granuloma, perforation, hemoptysis). |
| Percentage of procedures with clinical and functional improvement | 12 months | Percentage of procedures with clinical (dyspnea, cough, quality of life (VQ11 questionnaire)), and functional improvement (peak flow, forced expiratory volume in one second (FEV1)) at 3 months, 6 months and 12 months |
Countries
France
Contacts
CONTACTNicolas GUIBERT, MCU-PH
PRINCIPAL_INVESTIGATORNicolas GUIBERT, MD
University Hospital, Toulouse
Outcome results
None listed