Surgeons are running a clinical trial to find out whether removing only half the thyroid gland is enough for patients with low-risk thyroid cancer, or whether removing the whole gland—the current standard—is unnecessarily aggressive. This matters because thyroid cancer diagnoses are rising faster than any other tumour, yet survival rates for low-risk cases already exceed 98% at ten years. The existing evidence for less extensive surgery comes only from observational studies, which are prone to bias. Without a randomised trial, clinical teams lack clear guidance, leading to inconsistent practice and patient anxiety. If the trial shows that hemithyroidectomy is non-inferior to total thyroidectomy, the impact would be immediate and practical. Patients could avoid lifelong thyroid hormone replacement, reduce the risk of damage to the parathyroid glands and recurrent laryngeal nerve, and need fewer postoperative scans and treatments. The NHS would also save costs from shorter operations, fewer complications, and less long-term follow-up. The results would directly update UK, European, and US clinical guidelines, reshaping routine surgical care for thousands of patients each year.
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Research question Are patients with low risk differentiated thyroid cancer being over-treated by having a total thyroidectomy such that hemithyroidectomy is sufficient, or should total thyroidectomy remain as standard of care? Background The incidence of well-differentiated thyroid cancer (DTC) is increasing faster than any other tumour. Surgery is the most important prognostic determinant in the management of DTC. The current standard of care is total thyroidectomy (TT) with post-operative RAI ablation for all DTC >1cm which has excellent prognosis: 10-year overall survival is 98-99%, and recurrence rate 7% by 8 years. In recent years, some surgeons have started to use hemithyroidectomy (HT) for some patients but the current evidence base for HT consists only of observational studies. Comparison of outcomes between HT and TT will therefore be affected by bias and confounding. Differential interpretation and implementation of international guidelines by local clinical teams have resulted in variable practices and increased anxiety for patients. A randomised trial is required to compare HT with TT. Aims and objectives Primary objective: To determine whether hemithyroidectomy (HT) is an acceptable and cost-effective surgical procedure compared to total thyroidectomy (TT) in low risk thyroid cancer. Secondary objectives include: assessment of the anatomical site of recurrence, surgical morbidity, quality of life, and number and type of additional investigations and treatments. Methods The HoT trial is a multi-site non-inferiority trial. 456 low-risk patients diagnosed with DTC will be recruited from two groups; Group 1 (have already had HT with histology) - randomised 1:1 to a second operation (two-stage TT) or to surveillance only. Group 2 (DTC on cytology with no thyroid surgery yet) - randomised 1:1 to HT or a single-stage TT. Patients will be followed-up 2-4 weeks post-operation, at 6 months, and then annually for 6.5 years for the main analysis and funding period (and longer using electronic registry data). Follow-up assessments will include neck ultrasound, routine bloods (thyroid function, Tg, TgAb, calcium), voice assessment, and quality of life questionnaires. The primary outcome is 3 (and 5 year) recurrence rate, analysed as time-to-event data using Kaplan-Meier curves and Cox regression, i.e. time to recurrence. The primary analyses will be per protocol, and a secondary analysis by intention-to-treat. The cost-effectiveness of HT will be evaluated from a health and social services perspective over a 30 month and a lifetime horizon, including quality of life using the EQ-5D-5L at baseline, post-surgery, 6 months and then annually. Timelines for delivery The HoT trial is a 96 month project. Year 1 will be for trial set-up, obtaining approvals, and opening trial sites. Recruitment will be over a 4 year period incorporating an 18 month recruitment pilot phase. Anticipated impact and dissemination Trial findings will be used to revise and update national and international recommendations for routine practice, including the UK (BTA, ENT-UK), Europe (ETA) and the United States (ATA). Trial results will be disseminated at national/international conferences and published in high impact factor peer-reviewed journals. Results will also be disseminated via Patients’ associations through newsletters, journals, and bulletins, and via Cancer Research UK and the BAETS.
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