Informations générales (source: ClinicalTrials.gov)
Clinical Evaluation of Laryngeal Transplantation: Pilot Study of 3 Patients (ECLAT)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
septembre 2018
septembre 2030
20 juillet 2024
The experience of face and hand composite tissue transplantations reported in the
international community have mainly concerned trauma patients. Feasibility and individual
benefit have been demonstrated for these indications, in properly selected patients. The
first laryngeal transplantation also concerned a case of post-traumatic reconstruction. A
certain number of patients, who have suffered direct (extended period of intubation
during a stay in the ICU, road traffic accident etc.) or indirect trauma (thermal or
chemical burns) to the larynx, present irreversible trauma or injury to the larynx in
which conventional treatments are unable to restore laryngeal function. These patients
find themselves severely disabled, with a significant reduction in their quality of life.
They suffer from stigmatization which leads to social isolation (professional and
personal). In some circumstances, providing healthy tissue and anatomical or functional
components (cartilage, muscle, nerves, blood vessels) by means of an allogeneic laryngeal
transplantation, is the only way of allowing patients, whose quality of life has been
seriously affected, to speak, breath and swallow normally. The extremely promising
results from other international teams in this area have encouraged the investigators to
present this project.
The specificities of the protocol compared to previous transplantations carried out by
other teams are:
- The technique for nerve re-innervation which should make it possible to decannulate
all patients and improve functional outcomes in the graft.
- A dual therapy immunosuppressive regimen will be used, if the patient's clinical and
biological status permits, which can be adjusted according to the type of tissue
grafted.
It might be thought that the need for immunosuppressive therapy means the indications
will remain rare, representing an incidence of less than five patients a year in France.
However, the interest of this research project does not reside in the number of patients
concerned but rather the total lack of any existing therapeutic solution. Conducting a
case series will help determine whether, under certain conditions, laryngeal
transplantation can improve the management of patients for whom the usual reconstructive
surgery options are unsatisfactory.
The study is intended to provide a descriptive analysis of a case series of three
laryngeal transplantations before and after comparisons, each patient serving as their
own control.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon - 69003 - Lyon - France | Lionel BADET, MD | Contact (sur clinicalTrials) | |||
| Service ORL & Chirurgie Cervicofaciale - Hôpital Charles Nicolle - CHU Rouen - 76000 - Rouen - France | Jean-Paul MARIE, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de soins de suite et de réadaptation fonctionnelle - SSR Val Rosay - 69370 - Saint Didier au Mont d'Or - France | Cherryfat GIWA, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patients presenting with the permanent loss of laryngeal functions. Loss of
laryngeal function is considered when a patient is permanently tracheotomized, is
mutic and presented failure for each of the three conventional treatment.
Conventional treatment lines are organized in the following manner firstly laser,
then prosthesis and lastly surgery) Diet may be normal.
- Adults aged between 18 to 60 years;
- ASA (American Society of Anesthesiology) score < 3 and the health status of the
patients must be compatible not only with the graft but also with all the treatments
envisaged by the study (according investigator assessment);
- Psychological maturity: recipients should be psychologically balanced, assessed by
the team psychiatrists, have taken personality tests, determined and willing,
capable of understanding the information provided on the risks relating to the
surgery and the immunosuppressive treatment, and capable of making their own
decision regarding the transplantation. The psychological preparation for the
transplantation requires relationships to be built up prior to the procedure between
the patient, the team providing care for laryngectomized patients, the
rehabilitation team, the surgical team and the psychiatrist;
- Patients capable of understanding the information provided on the risks relating to
the study, and capable of making their own decision regarding the transplantation
according investigator assessment;
- Having given written informed consent prior to any procedure related to the study;
- Covered by a Health System where applicable, and/or in compliance with the
recommendations of the national laws in force relating to biomedical research.
- Patients presenting with the permanent loss of laryngeal functions. Loss of
laryngeal function is considered when a patient is permanently tracheotomized, is
mutic and presented failure for each of the three conventional treatment.
Conventional treatment lines are organized in the following manner firstly laser,
then prosthesis and lastly surgery) Diet may be normal.
- Adults aged between 18 to 60 years;
- ASA (American Society of Anesthesiology) score < 3 and the health status of the
patients must be compatible not only with the graft but also with all the treatments
envisaged by the study (according investigator assessment);
- Psychological maturity: recipients should be psychologically balanced, assessed by
the team psychiatrists, have taken personality tests, determined and willing,
capable of understanding the information provided on the risks relating to the
surgery and the immunosuppressive treatment, and capable of making their own
decision regarding the transplantation. The psychological preparation for the
transplantation requires relationships to be built up prior to the procedure between
the patient, the team providing care for laryngectomized patients, the
rehabilitation team, the surgical team and the psychiatrist;
- Patients capable of understanding the information provided on the risks relating to
the study, and capable of making their own decision regarding the transplantation
according investigator assessment;
- Having given written informed consent prior to any procedure related to the study;
- Covered by a Health System where applicable, and/or in compliance with the
recommendations of the national laws in force relating to biomedical research.
- Minors or patients aged over 60 years;
- Patients with a history of cancer of the upper airways or upper digestive tract;
- Patients with a history of other types of malignancy;
- Patients presenting with a progressive malignant tumor; suspicious laryngeal lesions
(dysplasia ...)
- Patients with addiction to alcohol and/or smoking
- Patient presenting hepatitis B, hepatitis C, or HIV(Human Immunodeficiency Virus)
infection;
- Patients with a history of psychiatric disorders: known delusional psychosis,
untreated severely depressed patients, patients with severe behavioral disorders,
patients with permanent generalized anxiety disorder,
- ASA (American Society of Anesthesiology) score ≥ 3;
- Patients presenting moderate renal failure which does not justify renal
transplantation with a glomerular filtration rate of less than 60 mL/min per 1.73 m2
calculated using the CKD-EPI formula;
- Arterial hypertension treated by more than one therapy;
- Testing for anti-HLA antibodies will be carried out at the initial inclusion visit,
a cross-match will be carried out immediately before transplantation, a positive
cross-match will be considered as an automatic contraindication to carrying out the
transplantation;
- Women who are pregnant or not taking contraception (effective contraceptive method
compulsory);
- Women who are breastfeeding;
- People who have been deprived of their freedom through a legal or administrative
decision;
- Adult with a legal guardian;
- Patients in emergency situations;
- EBV (Epstein-Barr Virus) seronegative recipient with EBV seropositive graft, due to
the risk of lymphoma.