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

Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules by Percutaneous Radiological Approach

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.

Study Overview

• Status: Completed
• Conditions: Benign Thyroid Nodules
• Intervention / Treatment: Procedure: Radiofrequency ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Renaud, MD; Phone Number: 33 5 67 77 17 78; Email: renaud.c@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31400
    • CHU Toulouse, Hôpital Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with radiofrequency; Treatment of symptomatic benign nodules with radiofrequency ablation as an alternative to surgical treatment	Procedure: Radiofrequency ablation; The procedure will include an ultrasound with radiofrequency ablation of the benign thyroid nodule percutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure response rate	First estimate of the procedure response rate (patient with complete procedure in percentage)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nodular volume	compared to the volume measured at inclusion. This reduction will be estimated in absolute value and in relative value (percentage reduction for a given subject)	at 6 and 12 months
volume change of nodules by at least 50 percent, at 6 months	Percentage of patients with a volume decrease of at least 50 percent, 6 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent	at 6 months
volume change of nodules by at least 50 percent, at 12 months	Percentage of patients with a volume decrease of at least 50 percent, 12 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent	at 12 months
complete disappearance of symptoms	The symptoms will be evaluated by a visual analogue scale of 0 to 10 as proposed by the Korean consensus. The symptoms assessed will be: cervical pain, dysphagia, foreign body sensation, discomfort, coughing.	at 12 months
aesthetic change	This improvement will be evaluated with a 4-level scale (no clinically detectable nodule 0, palpable nodule 1, visible nodule on swallowing 2, spontaneously visible nodule 3) as proposed by the Korean consensus. The improvement will be defined by the transition to the lower category.	at 3, 6 and 12 months
one or more complications	In particular, the following will be investigated: signs of cutaneous involvement such as burns, hematoma and intra-nodular bleeding, recurrent paralysis, superinfections, tracheal or esophageal wounds.	at 6 and 12 months
Assessment of pain during the procedure with visual analogue scale	Evaluation of the pain during the procedure using a visual analogue scale from 0 to 10 established at the end of the procedure	between Day 1 and Day 15
patients requiring L-thyroxine replacement therapy	Percentage of patients requiring L-thyroxine replacement therapy	at 6 and 12 months
Economic evaluation from the point of view of the hospital	evaluation, from the point of view of the hospital, of the production cost of the new technique	Between Day 1 and 12 months
patients who have used analgesics	Percentage of patients who have used analgesics during and after the procedure	between Day 1 and Day 15
Economic evaluation from the point of view of the health insurance	Evaluation, from the point of view of health insurance, of the cost of the care of patients who benefited from the new technique	Between Day 1 and 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): December 27, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: radiofrequency; benign thyroid nodule; symptomatic thyroid nodule
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule
• Other Study ID Numbers: RC31/17/0352; 2018-A00669-46 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No