Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules (TRAF)

Toulouse University Hospital

Status

Completed

Conditions

Benign Thyroid Nodules

Treatments

Procedure: Radiofrequency ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT03646383

2018-A00669-46 (Other Identifier)

RC31/17/0352

Details and patient eligibility

About

The purpose of the present protocol is to evaluate the response rate to treatment of these symptomatic benign nodules with radiofrequency as an alternative to surgical treatment.

This thyroid nodules ablation with radiofrequency will be directed by a single percutaneous procedure guided by ultrasound. The procedure includes an ultrasound with percutaneously radiofrequency ablation of benign thyroid nodule. Clinical and ultrasonographic monitoring will last a year with consultations at 2 weeks (consultation only), 3 months, 6 months and 1 year (consultation, ultrasound TSH). The success of this procedure will be controlled with 3 successive ultrasounds the following year. The expected results are a decrease in the size of the nodule by at least 50% and a reduction in the functional and aesthetic discomfort, with less frequent complication than what is expected with surgery. The present study also intends to determine the medico economic impact of this technique compared to surgery.

Full description

Thyroid benign nodules represent a major public health problem because they are very common (subclinical nodules were found in half of woman beyond 60 years). The main risk factors include age, female gender, parity, smoking and family history of thyroid nodules or thyroiditis. The assessment is based on biology, ultrasound and fine needle aspiration and intends to determine the benign nature (95%) or cancer (5%) of the nodules and if they are functional or not (toxic nodule). Most benign nodules are asymptomatic but some of them because of their size and location can cause a functional disorder (compression or swallowing disorder) or aesthetic and psychological resounding.In current practice, these nodules are sometimes treated with surgery that impact on patient quality of life (need to take L-Thyroxine, difficulties related to the possible occurrence of complications like hypoparathyroidism or laryngeal paralysis) and socio-economic constraints especially when complications occur. To limit the number of unnecessary and potentially risky surgeries, patients should therefore be well selected. If surgery is the preferred treatment of thyroid cancer, alternative techniques like radiofrequency seem interesting for benign nodules.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Euthyroid or hypothyroidism properly substituted with normal TSH
Benin nodule proved by FNA (Bethesda) and normal Calcitonin
Nodule size> 1cm and / or increase in size
Single nodule or asymptomatic nodules associated
Symptomatic nodule with functional impairment and / or aesthetic Patient Agreement
Patient with insurance coverage
Written agreement for participation

Exclusion criteria

The exclusion criteria are related to the histological nature of the nodule and the necessary of the procedure:

Allergy to local anesthetics
FNA non-contributory or suspicious nodule (Bethesda)
Multiple nodules more than 2cm
Hyperthyroidism or hyperparathyroidism associated requiring surgical intervention.
Taking a treatment with anticoagulant or double antiplatelet
Patient with a Pacemaker
Contralateral laryngeal paralysis in nodule
Purely cystic nodule
Nodule in contact with the recurrent nerve
Patient Refusal
Pregnant and breastfeeding women
Patient trust, guardianship or safeguard justice.