Inclusion criteria, exclusion criteria and study summary
The rate of well-differentiated thyroid cancer (DTC) is increasing faster than any other tumour. Currently, standard treatment for low-risk DTC is surgical removal of the whole thyroid gland called total thyroidectomy (TT), followed by radioiodine treatment. Recently, surgeons have started performing hemithyroidectomy (HT) (removal of the cancerous half of the thyroid) as international guidelines changed and studies suggested patients may benefit from less extensive surgery, whilst maintaining excellent cure rates. HT patients may not require life-long hormone replacement therapy, calcium and vitamin D supplements, and radioiodine treatment. However, results from these studies are biased and conflicting. There is uncertainty surrounding the most appropriate surgery causing variations in practice between different teams and hospitals. HoT is the first trial to directly compare TT versus HT in terms of the rate of cancer returning, impact on quality of life, surgery-related side-effects, need for thyroid hormone replacement therapy after surgery, health resources use and cost-effectiveness to the NHS. Patients who had a HT during diagnosis will be randomly assigned to receive regular surveillance only or have a second operation to remove the rest of their thyroid. Patients diagnosed with DTC but not undergone surgery, will be randomly assigned to have a HT or a single-stage TT. All patients will be followed-up regularly. HoT is funded by the National Institute for Health Research and plans to recruit ~456 patients over 4 years across UK hospitals. Patients will be monitored for up to 6½ years after surgery (last patient for ~2 ½ years). If we show HT is as effective as TT, HT would become nationally and internationally recommended for low-risk DTC patients. If HT proves less effective than TT, guidelines will make clear that HT should only be performed in selected cases, and TT preferred in most cases. This will improve treatment decision making.
