NCT05604963

Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 456 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centre, randomised, non-inferiority, phase III study in patients with low risk differentiated thyroid cancer. Patients will be identified via oncology multidisciplinary team meetings. There will be two sources of patients in the trial, with the same histological diagnoses and prognosis (i.e. recurrence risk): * Group 1: Patients who have already had a HT for thyroid problems and are then subsequently diagnosed with low risk DTC will be randomised 1:1 to undergo surveillance only OR a second operation to remove the rest of their thyroid gland (two-stage total thyroidectomy). * Group 2: Patients diagnosed with low risk DTC using cytology (Thy5) but no surgery performed will be randomised 1:1 to have either a hemi-thyroidectomy OR a single-stage total thyroidectomy. The overall aim of the trial is to determine whether hemithyroidectomy is an acceptable and cost-effective surgical procedure compared to total thyroidectomy in low risk thyroid cancer. Overall, 456 patients will be recruited to the trial. Patients will be initially be followed up post-surgery then 12 monthly for 6 years.

Conditions

• Differentiated Thyroid Cancer

Interventions

Type	Name	Description
PROCEDURE	Total Thyroidectomy	Total Thyroidectomy - surgical removal of entire thyroid gland
PROCEDURE	Hemithyroidectomy	Hemithyroidectomy - surgical removal of partial thyroid gland

Timeline

• Start date: 2022-02-14
• Primary completion: 2028-07-31
• Completion: 2031-07-31
• First posted: 2022-11-03
• Last updated: 2026-03-05

Locations

33 sites across 1 country: United Kingdom