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Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
Sponsor: University College, London
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.
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
456
Start Date
2022-02-14
Completion Date
2031-07-31
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Total Thyroidectomy
Total Thyroidectomy - surgical removal of entire thyroid gland
Hemithyroidectomy
Hemithyroidectomy - surgical removal of partial thyroid gland
Locations (33)
Leighton Hospital
Crewe, Cheshire, United Kingdom
Royal United Hospital
Bath, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Colchester Hospital
Colchester, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
NHS Lothian
Edinburgh, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Forth Valley Royal Hospital
Falkirk, United Kingdom
Medway Maritime Hospital
Gillingham, United Kingdom
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Liverpool University Hospitals
Liverpool, United Kingdom
Guy's Hospital
London, United Kingdom
Lister Hospital
London, United Kingdom
Northwick Park Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
The Royal Marsden Hospitals
London, United Kingdom
University College London Hospital
London, United Kingdom
Luton and Dunstable University Hospital
Luton, United Kingdom
Northampton General Hospital
Northampton, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Poole, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Glan Clwyd Hospital (Betsi Cadwaladr University Health Board)
Rhyl, United Kingdom
Sheffield Teaching Hospitals
Sheffield, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom