Laryngeal transplantation
Conditions
Interventions
Test Group:Simultaneous laryngal-tracheal transplantation after total laryngectomy
Control Group:non-simultaneous laryngal-tracheal transplantation after total laryngectomy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients enrolled in the experimental group must satisfy both (1), (2), (5), (6), (7) and (8) of the following criteria; patients enrolled in the control group must satisfy both (3), (4), (5), (6), (7) and (8) of the following criteria: (1) Patients who need 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) patients under 75 years old (including 75 years old) with urgent needs for voice function; (3) 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, recurrence of advanced thyroid cancer, etc.); (4) those who are under 75 years old (including 75 years old), have lived "laryngfree" for more than one year, and have an urgent need for voice function or are related practitioners who need to use voice frequently; (5) 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; (6) patients who are willing to take immunosuppressive drugs for life, or who have been required to take immunosuppressive drugs for life due to other causes (such as other organ transplantation, some rheumatic diseases, etc.); (7) Patients and their family members (main accompany) have certain language, reading, writing and communication skills to facilitate the filling of the questionnaire; (8) Voluntarily participate in the study after informed consent and can return to the hospital on time for follow-up.
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); (4) patients who suffered from mental or psychological disorders before total laryngectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative adverse event incidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Free Survival;Graft Survival;Rrecovery time of Voice function; | — |
Countries
China
Contacts
Public ContactChen Fei
West China Hospital, Sichuan University
Outcome results
None listed