Treatment of Central Airway Stenoses Using Computer-Assisted Customized 3d Stents TATUM
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 3D customized airway stents
|
Device: Custom-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
|
Outcome Measures
Primary Outcome Measures
- Percentage of procedures with clinical improvement of the dyspnea [12 months]
Percentage of procedures with clinical improvement of the dyspnea with questionnaires of Borg, 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Toulouse | Toulouse | France | 31000 |
Sponsors and Collaborators
- University Hospital, Toulouse
Investigators
- Principal Investigator: Nicolas GUIBERT, MD, University Hospital, Toulouse
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC31/19/0052