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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery of thyroid cancer | Active Comparator |
| |
| RFA of thyroid cancer | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation alone | Procedure | RFA of a cancer in the thyroid gland. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| One month after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Endocrinological 2 | Thyroid hormones are evaluated by biochemical measurements (mU/L). | At randomization (baseline), and at three months, 1, 2, 3, 4 and 5 years after randomization. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sofie Louise Rygaard, MD, PhD | Contact | +4551922819 | soryga@rm.dk | |
| Lars Rolighed, MD, PhD | Contact | larsroli@rm.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Aarhus University Hospital | Aarhus | 8200 | Denmark |
We plan to share data of the results from the primary and secondary outcomes.
Supporting information and IPD will be available by January 2026 and until January 2030.
By contact to the primary investigator and trial manager.
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Surgery |
| Procedure |
Hemithyroidectomy of the thyroid lobe with cancer |
|
| 5 years after randomization. |
| Endocrinological 1 | The need for substitutional treatment with thyroid hormones (dichotomous; yes/no) is included as secondary endpoint. | 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). | 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. | 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). | At randomization (baseline), and at three months, 1, 2, 3, 4, and 5 years after randomization. |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |