Malignancies, inflammatory diseases, traumas
Conditions
Interventions
tracheal reconstruction using an artificial trachea
Sponsors
Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Be able to comply with the trial protocol. Provide written informed consent. Have been diagnosed that (1) or (2) (1) tracheal stoma was not able to be reconstructed with existing treatment options. (2) no less than a half of the tracheal cartilage as well as three tracheal rings should be affected through resection of malignancies.
Exclusion criteria
Exclusion criteria: Have a bilateral vocal fold palsy. Have a severe cardiovascular, hematological, hepatic, digestive, renal, pulmonary, endocrine, neurological or psychiatric diseases. Severe hemorrhage or shock. Severe bacterial, viral or fungal infections. Keloid diathesis. A history of irradiation to the neck. Be indicated for any other treatments. Have a history of allergic reaction to a porcine collagen or polypropylene. Have participated in any other clinical trials, and an investigational agent has been administered within 12 weeks. Pregnant, lactating, or willing to be pregnant during the trial. Be concluded not eligible to enter the trial by a principle investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence (or absence) of tracheostomy stoma at 12 weeks after the procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of airway stenosis at 12 weeks after the procedure Degree of re-epithelialization of a luminal side of the artificial trachea at 12 weeks after the procedure modified Rankin Scale Respiratory assessment scale EQ5D-5L V-RQOL | — |
Countries
Japan
Contacts
Public ContactYo Kishimoto
Graduate school of Medicine, Kyoto University Department of Otolaryngology, Head and Neck Surgery
Outcome results
None listed