Laryngeal transplantation
Conditions
Interventions
Test Group:Combined laryngeal-tracheal-esophageal-thyroid multi-organ cluster transplantation
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Enrolled patients are required to fulfil the following conditions at the same time: (1) Patients who underwent total laryngectomy due to various causes (including but not limited to advanced laryngeal cancer, laryngeal cancer recurrence, hypopharyngeal and cervical esophageal cancer, tongue cancer, trauma, postoperative recurrence of advanced thyroid cancer, etc.); (2) Those who are under 75 years old, have lived "without laryngeal" for more than one year, and have an urgent need for voice function or are related practitioners who need to use throat frequently; (3) Patients with good general condition or combined with hypertension, diabetes, coronary heart disease, thyroid dysfunction, liver and kidney dysfunction and other basic diseases could be treated by surgery after multi-disciplinary consultation; (4) Willingness to take immunosuppressive drugs for life and the risks involved, or prior exposure to immunosuppressive drugs due to other causes (e.g.Other organ transplantation, some rheumatic diseases, etc.) patients who need life-long immunosuppressive drugs;
Exclusion criteria
Exclusion criteria: Patients were not enrolled if they met any of the following criteria: (1) Patients older than 75 years with no urgent need for laryngeal function such as voice function; (2) Patients with poor general condition who could not tolerate laryngotracheal transplantation and lifelong immunosuppressive therapy; (3) The patients were living with tumor after total laryngectomy (including but not limited to local recurrence, distant metastasis, and new tumors in other sites);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| European five-dimensional Health Scale score;Anderson Symptom Assessment Scale( Head and Neck) score;Self-rating Anxiety Scale score;Self-rating Depression Scale score;the grade, roughness, breathiness, asthenia, and strain (GRBAS) scale score;Vocal Handicap Index-10 (VHI-10) score;Objective acoustic analysis;Respiratory patency through larynx;Water swallow test;the M.D Anderson Dysphagia Inventory score;survival rate;Recurrence rate;Direct olfactory detection;Incidence of postoperative complications;Disease-free survival time;Qualitative research semi-structured interview; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of oral and facial function;Video Fluoroscopic Swallowing study;Fiberoptic Endoscopic Evaluation of Swallowing;Modified Penetration-aspiration Scale score;the Eating Assessment Tool score;Sense of Coherence Scale score;Sniffer stick test;Genomics;Metabonomics;Proteomics;Respiratory microecology;Intestinal microecology;Transplantation laryngeal mucosa immunohistochemistry; | — |
Countries
China
Contacts
Public ContactChen Fei
West China Hospital, Sichuan University
Outcome results
None listed