An interventional study of Radiofrequency ablation alone and Surgery in Thyroid Cancer, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
This is a multicenter randomized controlled trial including patients with small (\<2 cm) suspected or confirmed thyroid cancers. Patients are included after informed consent and randomized to one of two treatments. One treatment is a standard henithyroidectomy and the second treatment is radiofrequency ablation (RFA) of the specific tumor. The investigators will evaluate initial outcome of the allocated treatment, thyroid hormonal function, oncologic safety, quality of life, and treatment costs in a follow-up period of five years after treatment.
The overall aim of the study is to improve patient's health by reducing the number of operations on small thyroid cancers. In patients with these small tumors, the long-term adverse outcome may be higher than possible benefits from the operation. For participants undergoing surgical treatment with HT, the investigators will measure final histology and both beneficial and adverse outcome from the operation. For participants undergoing RFA, the investigators expect to reduce the need for thyroid hormonal substitutions, reduce the surgical adverse outcomes, reduce treatment costs and increase QoL without a reduction in oncologic safety and outcome.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's planned enrollment of 88 is above the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Surgery
Procedure: Radiofrequency ablation alone
RFA of a cancer in the thyroid gland.
Hemithyroidectomy of the thyroid lobe with cancer
Uncomplicated initial treatment (yes/no)
Uncomplicated treatment is defined as a composite endpoint (dichotomous; yes/no) with none of the following adverse outcomes within the first month after treatment/surgery: 1. short or long-term affection of the recurrent laryngeal nerve (RLN) based on laryngoscopy, 2. infection with a need for surgical treatment, 3. capsule rupture or bleeding with a need for operation, 4. prolonged hospital stay (more than one night), 5. any other reason for a secondary surgical intervention on the neck.
Time frame: One month after randomization.
Oncologic
Any oncologic events with either recurrence of disease in the thyroid gland or lymph node metastasis are included (dichotomous; yes/no). Developing disease in the contralateral side of the thyroid gland will also be described and evaluated and possibly treated. However, contralateral disease will not be classified as adverse outcome after initial treatment but rather classified as new disease (dichotomous; yes/no).
Time frame: 5 years after randomization.
Endocrinological 1
The need for substitutional treatment with thyroid hormones (dichotomous; yes/no) is included as secondary endpoint.
Time frame: At three months, 1, 2, 3, 4 and 5 years after randomization.
Patient-reported outcome 1
A patient reported outcome is collected with use of the thyroid specific questionnaire ThyPRO-39 (continuous outcome).
Time frame: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.
Health economics
Collective costs for treatment with a HT operation in general anesthesia and an in-hospital stay is much more expensive than RFA treatment in the outpatient clinic. The relation between total costs for HT versus RFA are close to 5:1 and all treatment related costs will be collected during the trial.
Time frame: At 5 years after randomization.
Patient-reported outcome 2
A patient reported outcome is collected with use of the thyroid specific questionnaire Voice Related QoL (V-RQoL) (continuous outcome).
Time frame: At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization.
Endocrinological 2
Thyroid hormones are evaluated by biochemical measurements (mU/L).
Time frame: At randomization (baseline), and at three months, 1, 2, 3, 4 and 5 years after randomization.
Plan to share: Yes — We plan to share data of the results from the primary and secondary outcomes.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Supporting information and IPD will be available by January 2026 and until January 2030.
Access criteria: By contact to the primary investigator and trial manager.
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