Clinical trial NCT03646383: Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules
Official title: Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules by Percutaneous Radiological Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Thyroid Nodules
Keywords: benign thyroid nodule
radiofrequency
symptomatic thyroid nodule
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedure response rate
timeFrame: 6 months
Secondary outcomes:
measure: Change in nodular volume
timeFrame: at 6 and 12 months
measure: volume change of nodules by at least 50 percent, at 6 months
timeFrame: at 6 months
measure: volume change of nodules by at least 50 percent, at 12 months
timeFrame: at 12 months
measure: complete disappearance of symptoms
timeFrame: at 12 months
measure: aesthetic change
timeFrame: at 3, 6 and 12 months
measure: one or more complications
timeFrame: at 6 and 12 months
measure: Assessment of pain during the procedure with visual analogue scale
timeFrame: between Day 1 and Day 15
measure: patients requiring L-thyroxine replacement therapy
timeFrame: at 6 and 12 months
measure: Economic evaluation from the point of view of the hospital
timeFrame: Between Day 1 and 12 months
measure: patients who have used analgesics
timeFrame: between Day 1 and Day 15
measure: Economic evaluation from the point of view of the health insurance
timeFrame: Between Day 1 and 12 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse, Hôpital Larrey
Study officials:
affiliation: University Hospital, Toulouse
name: Claire RENAUD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
citation: Fuller CW, Nguyen SA, Lohia S, Gillespie MB. Radiofrequency ablation for treatment of benign thyroid nodules: systematic review. Laryngoscope. 2014 Jan;124(1):346-53. doi: 10.1002/lary.24406. Epub 2013 Oct 22.
citation: Deandrea M, Sung JY, Limone P, Mormile A, Garino F, Ragazzoni F, Kim KS, Lee D, Baek JH. Efficacy and Safety of Radiofrequency Ablation Versus Observation for Nonfunctioning Benign Thyroid Nodules: A Randomized Controlled International Collaborative Trial. Thyroid. 2015 Aug;25(8):890-6. doi: 10.1089/thy.2015.0133. Epub 2015 Jul 13.
citation: Hong MJ, Na DG, Baek JH, Sung JY, Kim JH. Cytology-Ultrasonography Risk-Stratification Scoring System Based on Fine-Needle Aspiration Cytology and the Korean-Thyroid Imaging Reporting and Data System. Thyroid. 2017 Jul;27(7):953-959. doi: 10.1089/thy.2016.0603. Epub 2017 May 19.
citation: Chen F, Tian G, Kong D, Zhong L, Jiang T. Radiofrequency ablation for treatment of benign thyroid nodules: A PRISMA-compliant systematic review and meta-analysis of outcomes. Medicine (Baltimore). 2016 Aug;95(34):e4659. doi: 10.1097/MD.0000000000004659.