Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Oct 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether patients with low-risk papillary thyroid cancer (PTC) who undergo a specific type of surgery called lobectomy (removal of one lobe of the thyroid) can maintain healthy thyroid hormone levels without needing lifelong medication. The study aims to find out if keeping a certain hormone level (TSH) within a normal range after surgery can help improve patients' quality of life and reduce the need for thyroid hormone replacement therapy. Participants will be monitored for their thyroid hormone levels and overall health post-surgery.

To be eligible for this study, participants need to be between 18 and 70 years old, have a specific size of thyroid nodule, and must not have certain high-risk features like lymph node metastasis or extrathyroidal extension. They should also be in generally good health and able to provide informed consent. Throughout the trial, participants can expect regular check-ups and tests to monitor their thyroid health and treatment response. This study is open to all genders, and it aims to provide valuable insights that could improve treatment options for patients with low-risk thyroid cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1) Age 18-70 years old, ECOG score 0-2;
• • (2) Patients with the maximum diameter of unilateral thyroid nodules ≤4.0cm by ultrasound, papillary thyroid carcinoma diagnosed by preoperative cytology (Bethesda grade VI) or intraoperative freezing, and planned to undergo thyroid lobectomy;
• • (3) No clinical lymph node metastasis (cN0);No extrathyroidal extension, and the number of pathological lymph node micrometastasis (\<0.2cm) was ≤5.
• • (4) no serious medical diseases and major organ dysfunction, such as blood routine, liver, kidney, heart, lung function; No previous history of other head and neck malignancies, no history of neck radiation, no history of deep neck surgery (skin mass excision except clinical);
• • (5) Fully understand this study, have the ability to complete treatment, have follow-up conditions and voluntarily sign informed consent.
• Exclusion Criteria:
• • (1) History of malignancy in other sites (previous or simultaneous), excluding curable non-melanoma skin cancer and cervical carcinoma in situ;
• • (2) The contralateral thyroid nodules were evaluated by preoperative ultrasound, and the patients with suspicious nodules who underwent fine-needle aspiration cytology and could not confirm the benign or malignant nodules (Bethesda grade I, III-V) were excluded.
• • (3) Cervical lymph node metastasis was evaluated before surgery. Cytological aspiration and Tg eluent determination were performed on suspicious lymph nodes. If cytology was negative and Tg eluent was not higher than the normal range, it was not considered as exclusion criteria. The patients who were sent for intraoperative examination and showed metastasis were excluded.
• • (4) cytological aspiration or intraoperative freezing suspected non-papillary thyroid carcinoma (follicular carcinoma, medullary carcinoma, poorly differentiated or undifferentiated carcinoma) or high-risk subtypes of papillary thyroid carcinoma (high cell type);
• • (5) pregnant or lactating women；
• • (6) A history of drug use or drug abuse within the past 1 year;
• • (7) Participants who had participated in other clinical trials within 4 weeks before enrollment;
• • (8) The patient is unable to accept the preservation of the contralateral gland or cannot cooperate with subsequent thyroid hormone replacement therapy.
• • (9) The investigator assesses subjects who are unsuitable for the trial for other reasons, or who are not expected to complete the study.