The Importance of Thymus Anatomy to the Radical Resection of Thyroid Cancer Surgery and the Protection of Parathyroid Function

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how the anatomy of the thymus gland affects surgery for thyroid cancer. Thyroid cancer is a common type of cancer that can impact patients' health and quality of life. The goal of the study is to see if a thorough understanding of thymus anatomy during surgery can help remove hidden lymph nodes, potentially reducing the chance of cancer coming back and improving patient outcomes. By focusing on these details during surgery, doctors hope to lower the risk of complications and improve the overall success of the treatment.

To participate in this trial, patients need to be between 18 and 80 years old, have a diagnosis of thyroid cancer that requires surgery, and be in generally good health. They should also be willing to follow the study guidelines and provide informed consent. Participants can expect to undergo a total thyroid removal and lymph node dissection, with careful attention to the thymus area. This trial aims to enhance surgical techniques and ultimately improve recovery and survival rates for those with thyroid cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients diagnosed with thyroid cancer who require total thyroidectomy and bilateral central lymph node dissection.
• • The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
• • Age at the time of signing the informed consent form is between 18 and 80 years old, regardless of gender.
• • The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1.
• • Expected survival period is not less than 1 year.
• • Male and female patients of childbearing age agreed to use reliable methods of contraception before entering the trial, during the research process, and up to 8 weeks after discontinuation of medication.
• * Good organ function:
• • Hematology: Absolute neutrophil count (ANC) ≥ 1500/μ L; Platelets ≥ 100000/μ L; Hemoglobin ≥ 9.0g/dL or ≥ 5.6 mmol/L; Kidney: Serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance rate (CrCl) ≥ 60 mL/min (using the Cock Gault formula); Liver: For subjects with total bilirubin levels ≤ 1.5 × ULN or for subjects with total bilirubin levels\>1.5 × ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN; Endocrine system: Thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within the normal range at baseline, and if T3 and free T4 are within the normal range, the subject still meets the inclusion criteria; Coagulation function: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except for subjects undergoing anticoagulant therapy as long as PT or aPTT is within the prescribed range of use of the anticoagulant drug; Willing and able to comply with the visit, treatment plan, laboratory tests, and other research procedures outlined in the research plan.
• Exclusion Criteria:
• • There are locally advanced unresectable or metastatic diseases.
• • History of non infectious pneumonia/interstitial lung disease requiring steroid treatment, or current pneumonia/interstitial lung disease requiring steroid treatment.
• • Known history of active tuberculosis.
• • Known to have active infections that require systematic treatment.
• • Any subjects with known or suspected autoimmune diseases or immune deficiencies.
• • Uncontrolled active hepatitis B (defined as hepatitis B B virus surface antigen \[HBsAg\] test result in screening period is positive and HBV-DNA test value is higher than the upper limit of normal value in the laboratory department of the research center.
• • Subjects with HBV-DNA levels\<500 IU/mL within 28 days prior to randomization, who have received local standard antiviral treatment for at least 14 days and are willing to continue receiving antiviral treatment during the study period, are eligible for enrollment; Subjects with active hepatitis C (defined as those who test positive for hepatitis C virus surface antibody \[HCsAb\] and HCV-RNA during the screening period).
• • Known human immunodeficiency virus (HIV) infection (known to be HIV antibody positive).
• • Administer a live vaccine within 30 days prior to the first dose.
• • Have ≥ grade 2 peripheral neuropathy.
• • Has experienced severe allergic reactions to other monoclonal antibodies.
• • Known to have serious or uncontrolled underlying diseases; Including but not limited to hemodynamic instability cardiovascular events, symptomatic cerebrovascular events, and Child Pugh A or higher liver cirrhosis that occur within 6 months.