Patient-Customized Bioprinting Technology for Practical Regeneration of the Respiratory Tract (Trachea)

Inclusion Criteria:

1. Age Range:

   Individuals between 19 and 75 years of age are eligible for participation.
2. Specific Medical Condition:

   Patients must meet the following criteria and have thyroid or airway diseases necessitating partial or segmental resection:
   1. Thyroid Cancer Patients:

      For patients with thyroid cancer, inclusion is based on TNM staging, specifically stage II or higher differentiated thyroid cancer patients. Verification of complete removal through a freeze section test during surgery in accordance with the staging system for papillary carcinoma of the trachea is essential (Hum Pathol. 1993 Aug; 24(8):866-70).

      Patients for whom conventional reconstruction methods, including single-stage anastomosis, are infeasible and require alternative approaches like flap reconstruction.

      Patients suitable for single anastomosis, but assessed to derive more benefits than risks from 3D bioprinting, considering factors such as post-surgery aftereffects, complications, prolonged recovery, and potential decline in quality of life due to surgical intervention.
   2. Defect Size Patients with defects encompassing more than 30% of the cartilage around the affected organ are eligible. Smaller defects may also qualify if reinforcing defects using soft tissue is infeasible due to factors such as surrounding inflammation, tissue instability, tissue adhesion, unstable blood supply, or the anticipation of reoperation during reconstruction.
3. Pregnancy Consideration:

   In the case of childbearing women, individuals must provide a negative result on a pregnancy test and commit to using contraception throughout the clinical study period.
4. Informed Consent:

Participants must voluntarily provide written consent after receiving a comprehensive explanation of the clinical study.

Exclusion Criteria:

1. Pregnancy and Lactation:

   Pregnant or lactating women are excluded from participation in the study.
2. Prior Thyroid or Airway Surgery:

   Individuals who have undergone thyroid or airway peripheral surgery before undergoing screening are ineligible for participation.
3. Persistent Inflammation:

   Patients with ongoing inflammation of the thyroid or surrounding tissues at the time of screening are excluded.
4. Systemic Inflammatory Disease:

   Patients diagnosed with systemic inflammatory diseases at the screening stage are not eligible to participate.
5. Anesthesia Risk Factors:

   Individuals with a high risk of complications associated with general anesthesia due to existing liver disease, kidney disease, or heart disease are excluded.
6. Sepsis:

   Patients diagnosed with sepsis at the time of screening are not eligible for participation.
7. Hemorrhage Predisposition:

Individuals with a predisposition to hemorrhage at the time of screening are excluded from the study.