Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2022-12-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Benign Thyroid Nodules

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with radiofrequency

Treatment of symptomatic benign nodules with radiofrequency ablation as an alternative to surgical treatment

Group Type EXPERIMENTAL

Radiofrequency ablation

Intervention Type PROCEDURE

The procedure will include an ultrasound with radiofrequency ablation of the benign thyroid nodule percutaneously

Interventions

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Radiofrequency ablation

The procedure will include an ultrasound with radiofrequency ablation of the benign thyroid nodule percutaneously

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No