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Completed

NCT Number: NCT03646383

Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules

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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Key information

Conditions

Benign Thyroid Nodules

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse, Hôpital Larrey

Toulouse, 31400, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency ablation

Procedure

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

Primary outcomes

  1. Procedure response rate

    Time frame: 6 months

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

Secondary outcomes

  1. Change in nodular volume

    Time frame: at 6 and 12 months

    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)

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

    Time frame: 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

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

    Time frame: 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

  4. complete disappearance of symptoms

    Time frame: at 12 months

    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.

  5. aesthetic change

    Time frame: at 3, 6 and 12 months

    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.

  6. one or more complications

    Time frame: at 6 and 12 months

    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.

  7. Assessment of pain during the procedure with visual analogue scale

    Time frame: between Day 1 and Day 15

    Evaluation of the pain during the procedure using a visual analogue scale from 0 to 10 established at the end of the procedure

  8. patients requiring L-thyroxine replacement therapy

    Time frame: at 6 and 12 months

    Percentage of patients requiring L-thyroxine replacement therapy

  9. Economic evaluation from the point of view of the hospital

    Time frame: Between Day 1 and 12 months

    evaluation, from the point of view of the hospital, of the production cost of the new technique

  10. patients who have used analgesics

    Time frame: between Day 1 and Day 15

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

  11. Economic evaluation from the point of view of the health insurance

    Time frame: Between Day 1 and 12 months

    Evaluation, from the point of view of health insurance, of the cost of the care of patients who benefited from the new technique

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: TRAF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 24, 2018
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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