Thyroxine Replacement Therapy After Lobectomy for Low-risk Papillary Thyroid Carcinoma
Status:
Recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 2
Details
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences