Radiofrequency Ablation Versus Hemithyroidectomy for Small Thyroid Cancers
ConditionThyroid Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Single tumor in the thyroid gland with a FNAB suspecious of cancer or diagnostic of cancer (category V or VI in the Bethesda system)
tumor size of less than 2 cm in all dimensions.
Disqualifiers
suspicion of disseminated disease because of PET-positive lymph nodes ; suspect lymph-nodes by ultrasonography (US); or signs of capsular invasion of the tumor OR
tumor not eligible for RFA treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium > 1.32 mmol/L and PTH > 6 pmol//L ) OR
if the patient is pregnant OR
If the patient is unable to give informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
Radiofrequency ablation alone
Procedure/SurgeryRFA of a cancer in the thyroid gland.
Surgery
Procedure/SurgeryHemithyroidectomy of the thyroid lobe with cancer
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Surgery of thyroid cancerActive comparator 1 intervention
Group B: RFA of thyroid cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Other outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov