Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules

NCT03646383 | Completed

• 2 other identifiers: RC31/17/03522018-A00669-46
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Thyroid Nodules

Keywords

benign thyroid nodule; radiofrequency; symptomatic thyroid nodule

Outcome Measures

Primary Outcomes (1)

• Procedure response rate

  First estimate of the procedure response rate (patient with complete procedure in percentage)

  6 months

Secondary Outcomes (11)

• Change in nodular volume

  at 6 and 12 months

• volume change of nodules by at least 50 percent, at 6 months

  at 6 months

• volume change of nodules by at least 50 percent, at 12 months

  at 12 months

• complete disappearance of symptoms

  at 12 months

• aesthetic change

  at 3, 6 and 12 months

Study Arms (1)

Treatment with radiofrequency

EXPERIMENTAL

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

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablation PROCEDURE

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

Treatment with radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse, Hôpital Larrey

Toulouse, 31400, France

Location

Related Publications (5)

• 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.

  PMID: 26462967 BACKGROUND

• 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.

  PMID: 24122763 BACKGROUND

• 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.

  PMID: 26061686 BACKGROUND

• 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.

  PMID: 28463597 BACKGROUND

• 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.

  PMID: 27559968 BACKGROUND

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Claire RENAUD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: August 24, 2018
• Study Start: January 29, 2019
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)