Rehabilitation of the larynx after total laryngectomy using an aortic graft
Placement of a Laryngeal Allograft Aortic Implant After Total Laryngectomy to Rehabilitate Laryngeal Function
This study is testing if using a special graft made from aorta tissue can help people who have had their larynx removed due to cancer breathe and swallow better after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04650919 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients undergoing total laryngectomy due to advanced laryngeal cancer. It aims to evaluate the use of a stented aortic allograft for reconstructing the larynx, which may help restore a common passage for respiration and swallowing. The study involves surgical intervention and the use of human tissue to improve post-operative quality of life. The trial seeks to address the significant challenges faced by patients after laryngectomy, particularly the need for a tracheostoma.
Who should consider this trial
Good fit: Ideal candidates are patients with laryngeal cancer requiring total laryngectomy who can provide informed consent and understand the study's objectives.
Not a fit: Patients with contraindications to general anesthesia or those with extensive tumor spread may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients by restoring normal respiratory and swallowing functions.
How similar studies have performed: While there have been efforts to restore phonatory function post-laryngectomy, this specific approach using an aortic graft is novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with carcinomatous pathology of the upper airways requiring total laryngectomy * Patient affiliated to a social health insurance scheme (beneficiary or beneficiary's successor) * Patient speaks and reads French, understands the objectives and risks of the research and is able to provide dated and signed informed consent. * Patient having been informed of the results of the prior medical examination * For a woman with the ability to procreate: negative blood pregnancy test (verified during preoperative blood work) and effective contraception throughout the study. Exclusion Criteria: * Patient with a contraindication to general anaesthesia and/or iodinated contrast agents * Breastfeeding woman * Patient with a WHO performance index of grade strictly greater than 2 at the inclusion visit * Patient with subglottic or basi-lingual tumour extension greater than 1 cm (by endoscopic control and CT scan) * Patient having undergone cervico-facial radiotherapy prior to surgical management * Patient suffering from severe coagulation disorders (checked during the blood test performed as part of the standard care to make the diagnosis of cancer) * Patient with a history of allergy to DMSO, DHEA, clindamycin, gentamicin, vancomycin used for graft treatment and preservation * Inability to give informed information about the patient (patient in emergency situations, difficulties in understanding the patient) * Patient in exclusion period (determined by a previous or ongoing study) * Patient under safeguard of justice * Patient under guardianship,curatorship, family guardianship * Any situation considered by the operating physician as falling under a non-inclusion criterion * Patient suffering from a decompensated psychiatric pathology or at risk of decompensation, which may interfere with the follow-up modalities in the research setting.
Where this trial is running
Strasbourg
- ENT department-Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Christian DEBRY, MD PhD — Hôpitaux Universitaires de Strasbourg
- Study coordinator: Christian DEBRY, MD PhD
- Email: christian.debry@chru-strasbourg.fr
- Phone: +33 (0)3 88 12 76 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.