Background@#Postoperative
thyroid stimulating hormone (TSH)
suppression therapy is recommended for
patients with intermediate- and high-
risk differentiated
thyroid cancer to prevent the
recurrence of
thyroid cancer . With the recent increase in small
thyroid cancer cases, the extent of resection during
surgery has generally decreased. Therefore, questions have been raised about the
efficacy and long-term side effects of TSH
suppression therapy in
patients who have undergone a lobectomy. @*
Methods @#This is a multicenter, prospective, randomized,
controlled clinical trial in which 2,986
patients with
papillary thyroid cancer are randomized into a high-TSH group (intervention) and a low-TSH group (control) after having undergone a lobectomy. The principle of
treatment includes a TSH-lowering regimen aimed at TSH levels between 0.3 and 1.99 μIU/mL in the low-TSH group. The high-TSH group targets TSH levels between 2.0 and 7.99 μIU/mL. The
dose of levothyroxine
will be adjusted at each visit to maintain the target TSH level. The primary outcome is
recurrence -free
survival , as assessed by
neck ultrasound every 6 to 12 months.
Secondary endpoints include
disease-free survival , overall
survival , success rate in reaching the TSH target range, the proportion of
patients with major
cardiovascular diseases or
bone metabolic disease , the
quality of life , and medical
costs . The follow-up period is 5 years. @*Conclusion@#The results of this trial
will contribute to establishing the optimal indication for TSH
suppression therapy in low-
risk papillary thyroid cancer patients by evaluating the benefit and harm of lowering TSH levels in terms of
recurrence , metabolic
complications ,
costs , and
quality of life .