Radiofrequency Ablation Versus Hemithyroidectomy of Small Thyroid Cancers

University of Aarhus

Status

Not yet enrolling

Conditions

Thyroid Cancer

Treatments

Procedure: Surgery

Procedure: Radiofrequency ablation alone

Study type

Interventional

Funder types

Other

Identifiers

NCT06796348

RFARCT8200

Details and patient eligibility

About

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.

Enrollment

88 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.