Aortic Laryngeal Rehabilitation Graft

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Nov 24, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients who have undergone total laryngectomy, a surgery that removes the larynx (or voice box) due to laryngeal cancer. The goal is to use a special type of graft made from the aorta, which is the main artery in the body, to create a new structure that can help restore breathing, swallowing, and speaking functions. This approach aims to improve the quality of life for patients by reducing the need for a permanent tracheotomy, which is a hole in the neck used for breathing after the surgery.

To be eligible for the trial, patients must have a diagnosis of cancer in the upper airways that requires total laryngectomy and must be able to read and understand French to give their consent. Participants can expect to be closely monitored throughout the study to assess how well the new graft helps restore their functions. It's important to note that some patients may not qualify due to specific health conditions or previous treatments. Overall, this trial represents an exciting step forward in improving the lives of those affected by laryngeal cancer.

Gender

ALL

Eligibility 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.