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Sequential clinical study of combined laryngeal-tracheal-thyroid multi-organ cluster transplantation

Sequential clinical study of combined laryngeal- tracheal-thyroid multi-organ cluster transplantation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080222
Enrollment
Unknown
Registered
2024-01-24
Start date
2023-11-21
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal transplantation

Interventions

Intervention group:According to the condition of patients who met the inclusion and exclusion criteria, performing laryngrelated multiple organ cluster transplantation (including trachea, tongue, hypo

Sponsors

West China Hospital, Sichuan University,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with advanced laryngeal cancer, oesophageal cancer of the hypopharyngeal neck segment, and tongue cancer Patients shall meet the following criteria: 1) Pathologically confirmed laryngeal cancer or oesophageal cancer of the hypopharyngeal neck segment or tongue cancer without distant metastasis requiring total laryngectomy; 2) Patients who have already undergone total laryngectomy for laryngeal cancer or other diseases; 3) Patients who are less than 75 years old and have urgent requirements for vocal function; 4) Patients with well basic conditions ; 5) Patients who are willing to take lifelong immunosuppressive drugs; (2) Patients with severe laryngotracheal stenosis Patients must meet the following criteria: 1) patients with severe laryngotracheal stenosis who are unable to remove the tracheal tube after at least one failed conventional surgical repair; 2) Patients who need to wear an endotracheal tube for a long period of time to satisfy their respiratory needs. 3) Patients who are less than 75 years old and have urgent requirements for vocal function: 4) Patients with good general basic conditions: 5) Patients who are willing to undertake lifelong immunosuppressive drugs; (3) Locally advanced thyroid cancer Enrolled patients must fulfil the following criteria: Patients with recurrence after at least one surgery requiring total laryngeal (partial laryngeal) and long-segment tracheal (oesophageal) resection.

Exclusion criteria

Exclusion criteria: (1) Patients with advanced laryngeal cancer, oesophageal cancer of the hypopharyngeal neck segment, and tongue cancer If patients meet any of the following criteria, they cannot be enrolled: 1) With distant metastasis 2) patients who are older than 75 years old and do not have urgent requirements for vocal function; 3) patients with poor general condition who cannot afford laryngotracheal transplantation and lifelong immunosuppressive therapy; (2) Patients with severe laryngotracheal stenosis Patients will not be enrolled if they fulfil any of the following criteria: 1) Patients who are older than 75 years old and have no urgent need for vocal function; 2) Patients with poor general condition who cannot afford laryngotracheal transplantation and lifelong immunosuppressive therapy; 3) Patients who can have their narrow laryngotracheal tubes restored by conventional surgery and whose respiratory needs can be met by translaryngeal airflow;

Design outcomes

Primary

MeasureTime frame
Routine blood tests (haematology, biochemistry, etc.);Infection-related tests (sputum culture, urine culture, etc.);Tests related to immune rejection (tacrolimus dosing concentration, TBNK cell count, etc.);Endocrine metabolism-related tests (thyroid function, PTH, etc.);Situation of sound recovery;Patency of the respiratory tract;Surgical related complications;Postoperative quality of life;Survival rate;Survival rate (Transplanted organ cluster);Improvement of quality of life;

Secondary

MeasureTime frame
Transcriptomics;Metabolomics;Proteomics ;Respiratory microecology;Intestinal microecology;Postoperative recurrence rate;

Countries

China

Contacts

Public ContactChen Fei

West China Hospital, Sichuan University,

hxchenfei@163.com+86 189 8060 2124

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026