Actively Recruiting
Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2023-10-17
140
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 the number of pathological lymph node micrometastases (\<0.2cm) ≤5 were defined as the low recurrence risk group. After total thyroidectomy and radioiodine treatment, the probability of disease-free status (irritant Tg\<1ng/ml, no evidence of other disease recurrence) is about 78%-91%, and the probability of structural recurrence is about 1%-10%. In recent years, due to the further understanding of PTC, surgeons tend to become more conservative in treatment, such as active observation or reducing the extent of surgery. The indication for lobectomy has been extended to tumors \<4cm without extrathyroidal extension and clinical lymph node metastasis. For patients treated with lobectomy, current guidelines recommend that Thyroid Stimulating Hormone (TSH) be controlled at 0.5-2 mU/L, but evidence on the prognostic benefits of this TSH inhibition range is lacking.In recent years, a number of studies have suggested that if postoperative TSH in low-risk patients after lobectomy is acceptable within the reference range, it means that a considerable number of patients have a high probability of not receiving thyroxine replacement therapy after surgery, which can significantly improve their quality of life.A previous retrospective study from our institute showed no significant association between TSH levels after lobectomy and prognosis.The aim of this study was to evaluate the benefits and risks of postoperative TSH levels within the reference range (0.4-5 mU/L) in patients with low-risk papillary thyroid cancer who underwent lobectomy.In order to improve the effect of longer recurrence and death time of PTC, the investigators also performed postoperative thyroglobulin and its antibody for short-term treatment response evaluation.
CONDITIONS
Official Title
Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old, with an ECOG performance status of 0 to 2
- Unilateral thyroid nodules 4.0 cm or smaller by ultrasound
- Papillary thyroid carcinoma confirmed by preoperative cytology (Bethesda grade VI) or intraoperative freezing
- Planned to undergo thyroid lobectomy
- No clinical lymph node metastasis (cN0) and no extrathyroidal extension
- Five or fewer pathological lymph node micrometastases smaller than 0.2 cm
- No serious medical diseases or major organ dysfunction, including normal blood, liver, kidney, heart, and lung function
- No previous history of other head and neck cancers, neck radiation, or deep neck surgery except skin mass removal
- Ability to understand the study, complete treatment, and attend follow-up visits
- Voluntarily sign informed consent
You will not qualify if you...
- History of other cancers except curable non-melanoma skin cancer and cervical carcinoma in situ
- Suspicious nodules in the opposite thyroid lobe without a confirmed benign or malignant diagnosis by fine-needle aspiration cytology (Bethesda grades I, III-V)
- Cervical lymph node metastasis detected before surgery or during intraoperative examination
- Suspected non-papillary thyroid carcinoma or high-risk papillary thyroid carcinoma subtypes by cytology or intraoperative freezing
- Pregnant or lactating women
- History of drug use or abuse in the past year
- Participation in other clinical trials within 4 weeks before enrollment
- Unable to preserve the opposite thyroid gland or unable to cooperate with thyroid hormone replacement therapy
- Considered unsuitable for the trial or unlikely to complete the study by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
J
jie liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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