Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules
- Conditions
- Benign Thyroid Nodules
- Interventions
- Procedure: Radiofrequency ablation
- Registration Number
- NCT03646383
- Lead Sponsor
- University Hospital, Toulouse
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment with radiofrequency Radiofrequency ablation Treatment of symptomatic benign nodules with radiofrequency ablation as an alternative to surgical treatment
- Primary Outcome Measures
Name Time Method Procedure response rate 6 months First estimate of the procedure response rate (patient with complete procedure in percentage)
- Secondary Outcome Measures
Name Time Method Change in nodular volume 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)
volume change of nodules by at least 50 percent, at 6 months 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
volume change of nodules by at least 50 percent, at 12 months 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
complete disappearance of symptoms 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.
aesthetic change 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.
one or more complications 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.
Assessment of pain during the procedure with visual analogue scale 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
patients requiring L-thyroxine replacement therapy at 6 and 12 months Percentage of patients requiring L-thyroxine replacement therapy
Economic evaluation from the point of view of the hospital Between Day 1 and 12 months evaluation, from the point of view of the hospital, of the production cost of the new technique
patients who have used analgesics between Day 1 and Day 15 Percentage of patients who have used analgesics during and after the procedure
Economic evaluation from the point of view of the health insurance 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
Trial Locations
- Locations (1)
CHU Toulouse, Hôpital Larrey
🇫🇷Toulouse, France