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Abstract
Anatomically complex airway stenosis (ACAS) represents a challenging situation in which commercially available stents often result in migration or granulation tissue reaction due to poor congruence. This proof-of-concept clinical trial investigated the feasibility and safety of computer-assisted designed (CAD) and manufactured personalised three-dimensional (3D) stents in patients with ACAS from various origins. After CAD of a virtual stent from a CT scan, a mould is manufactured using a 3D computer numerical control machine, from which a medical-grade silicone stent is made. Complication rate, dyspnoea, quality of life and respiratory function were followed after implantation. The congruence of the stent was assessed peroperatively and at 1 week postimplantation (CT scan). The stent could be implanted in all 10 patients. The 3-month complication rate was 40%, including one benign mucus plugging, one stent removal due to intense cough and two stent migrations. 9 of 10 stents showed great congruence within the airways, and 8 of 10 induced significant improvement in dyspnoea, quality of life and respiratory function. These promising outcomes in highly complex situations support further investigation on the subject, including technological improvements.
Trial registration number NCT02889029.
- bronchoscopy
- lung transplantation
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Footnotes
Presented at Portions of these data were presented as an oral communication at ATS Annual Meeting, 2018.
Contributors NG: principal investigator of the work, conception and design of the work, computer-aided design of the stents, stent implantation, acquisition and interpretation of data, drafting the manuscript. AD: conception and design of the work, interpretation of data, revising the manuscript, approved the final version of the manuscript. BM: computer-aided design of the stents, manufacturing moulds, approved the final version of the manuscript. BL: conception and design of the work, statistical analysis of data, approved the final version of the manuscript. PL: computer-aided design of the stents, manufacturing moulds, approved the final version of the manuscript. GP: conception and design of the work, stent implantation, acquisition and interpretation of data, approved the final version of the manuscript. LM: acquisition and interpretation of data, approved the final version of the manuscript. MM: interpretation of data, approved the final version of the manuscript. JM: conception and design of the work, acquisition and interpretation of data, revising the manuscript, approved the final version of the manuscript. CH: conception and design of the work, computer-aided design of the stents, implantation of stents, acquisition and interpretation of data, approved the final version of the manuscript.
Funding This study was funded by ADERSPOT (Association pour le Développement de l"Enseignement, de la Recherche et des Soins en Pneumo-Oncologie de Toulouse) and AnatomikModeling.
Competing interests BM and PL are employees of AnatomikModeling.
Patient consent for publication Not required.
Ethics approval Our study was approved by local ethical instances (CPP) and by the National Agency of Medical Devices (ANSM).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All individual de-identified participant data will be shared, as well as study protocol, statistical analysis plan, informed consent form, clinical study report and analytical code, to any researcher who provides a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to guibert.n@chu-toulouse.fr. To gain access, data requestors will need to sign a data access agreement. Data are available immediately and indefinitely.