Status:
RECRUITING
Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Thyroid Cancer
Surgery
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis.According to the 2015 American thyroid association (ATA) guidelines, no gross extrathyroidal extension and ...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06087068
Start Date
August 1 2022
End Date
December 31 2026
Last Update
October 17 2023
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021