RecruitingNot ApplicableNCT04650919

Aortic Laryngeal Rehabilitation Graft

Placement of a Laryngeal Allograft Aortic Implant After Total Laryngectomy to Rehabilitate Laryngeal Function


Sponsor

University Hospital, Strasbourg, France

Enrollment

4 participants

Start Date

Mar 29, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The larynx is a cartilaginous organ of the respiratory system located in the throat, which plays an essential role in respiratory function, swallowing and sound production. In the case of advanced tumours, the surgical option most often remains total laryngectomy, with the corollary of a major impact on quality of life, not so much because of the loss of voice, but because of the presence of a definitive tracheostoma with particularly deleterious consequences. The majority of the work of the different teams around the world has focused on restoring phonatory function, but no technique - apart from the artificial larynx developed in the ENT department of the Hautepierre Hospital - has yet succeeded in removing the tracheotomy orifice, requiring the restoration of a common passage between the respiratory and swallowing passages. If nutrition and phonatory function can still be supplemented after such an operation (oesophageal rehabilitation, implant placed between the trachea and oesophagus), natural breathing is no longer possible. Patients are forced to wear a permanent tracheotomy opening. There are currently only 2 ways to try to restore all the functions of the larynx after total laryngectomy: i) laryngeal transplantation, but this procedure requires maintaining immunosuppressive treatment, which is not possible in patients suffering from cancer of the larynx, which is not a vital organ, ii) artificial larynx made of biomaterials (titanium), the first cases of which were performed worldwide in the ENT department of the Strasbourg University Hospital in 2012, results published in the NEJM (API 2008-2009 HUS No. 4493- IDRCB No.: 2011-A00032-39. However, difficulties were encountered with the use of the titanium prosthesis due to the bulk and rigidity of the removable and non-removable part, which caused residual swallowing difficulties (false routes). It is now possible, due to the development of new allograft techniques in humans for tracheal replacement (studies published on a large number of cases with several years of hindsight, cf. references), to switch to the "all biological" using an aortic graft stented with a silicone stent. We wish to use these grafts in laryngeal restoration after total laryngectomy by our team, while exploiting all the data and experience acquired (unique in the world) within the ENT department of Hautepierre Hospital. This new conceptual leap should make it possible to significantly improve the patient's quality of life and the performance previously acquired in clinical trials on the artificial larynx in its entirety (breathing, phonation) or partially (swallowing). The investigators thus propose to evaluate this new artificial larynx in aortic allograft, the objective of which is to supplement the respiratory, swallowing and phonation functions in patients laryngectomized for carcinological causes.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This French surgical trial tests a new type of laryngeal (voice box) replacement using a specially treated aortic graft in patients who need to have their voice box removed due to cancer of the upper airways. **You may be eligible if...** - You have a cancer of the upper airways that requires total removal of the voice box (total laryngectomy) - You are covered under a French social health insurance scheme - You can read and understand French and can provide informed consent - You have a negative pregnancy test (if you are a woman of childbearing age) **You may NOT be eligible if...** - You have a contraindication to general anesthesia or contrast dyes - You are breastfeeding - Your cancer extends more than 1 cm below the voice box or to the base of the tongue - You have previously had radiation to the head and neck area - You have severe blood clotting disorders - You have an allergy to certain preservation agents used in the graft procedure Talk to your doctor to see if this trial is right for you.

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Interventions

PROCEDURETotal laryngectomy and reconstruction by stented aortic allograft (using human tissue and device).

The procedure consists of 2 operating times: * Surgery S1 (1st surgical procedure): total laryngectomy and placement of the stented aortic graft (human tissue + device: NOVATECH GSS TM (trademark) TD), under tracheotomy cover. * Surgery S2 (2nd surgical procedure) (between S1 +24 weeks and S1 +36 weeks) : opening of the proximal part of the graft by endoscopic way with maintenance of the tracheotomy orifice to ensure patient safety.


Locations(1)

ENT department-Hôpitaux Universitaires de Strasbourg

Strasbourg, France

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NCT04650919


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