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Benign Thyroid NodulesTRAFNCT03646383

Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules

A study testing Radiofrequency ablation in people with Benign Thyroid Nodules, run by University Hospital, Toulouse at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Benign Thyroid Nodules
What is being tested?
Radiofrequency ablation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
29 Jan 2019to 27 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Toulouse, Hôpital Larrey

    Toulouse, 31400

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Radiofrequency ablation
Keywords
benign thyroid nodule, radiofrequency, symptomatic thyroid nodule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiofrequency ablationProcedure or surgery

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

Study groups in NCT03646383
Study groupRoleWhat they receive
Treatment with radiofrequencyExperimentalTreatment of symptomatic benign nodules with radiofrequency ablation as an alternative to surgical treatment
Receives: Procedure: Radiofrequency ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedure response rate

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

    Measured: 6 months

Secondary outcomes (11)

  1. 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)

    Measured: at 6 and 12 months

  2. 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

    Measured: at 6 months

  3. 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

    Measured: at 12 months

  4. 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.

    Measured: at 12 months

  5. 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.

    Measured: at 3, 6 and 12 months

  6. 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.

    Measured: at 6 and 12 months

  7. 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

    Measured: between Day 1 and Day 15

  8. patients requiring L-thyroxine replacement therapy

    Percentage of patients requiring L-thyroxine replacement therapy

    Measured: at 6 and 12 months

  9. 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

    Measured: Between Day 1 and 12 months

  10. patients who have used analgesics

    Percentage of patients who have used analgesics during and after the procedure

    Measured: between Day 1 and Day 15

  11. 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

    Measured: Between Day 1 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2018
  2. Study start29 Jan 2019
  3. Primary completion27 Dec 2022
  4. Study completion27 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03646383
Sponsor's protocol ID
RC31/17/0352
Other IDs
2018-A00669-46
Acronym
TRAF
Status last verified
Mar 2023
First submitted
25 Mar 2018
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26462967

  • 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.

    PubMed 24122763

  • 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.

    PubMed 26061686

  • 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.

    PubMed 28463597

  • 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.

    PubMed 27559968

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency ablation in people with Benign Thyroid Nodules, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03646383, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.

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