Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules (TRAF)
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|ClinicalTrials.gov Identifier: NCT03646383|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : April 3, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Benign Thyroid Nodules||Procedure: Radiofrequency ablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules by Percutaneous Radiological Approach|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
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
- Procedure response rate [ Time Frame: 6 months ]First estimate of the procedure response rate (patient with complete procedure in percentage)
- 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)
- 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
- 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
- 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.
- 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.
- 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.
- 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
- patients requiring L-thyroxine replacement therapy [ Time Frame: at 6 and 12 months ]Percentage of patients requiring L-thyroxine replacement therapy
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646383
|Contact: Claire RENAUD, MD||5 67 77 17 78 ext email@example.com|
|CHU Toulouse, Hôpital Larrey||Recruiting|
|Toulouse, France, 31400|
|Contact: Claire Renaud, MD 5 67 77 17 78 ext 33 firstname.lastname@example.org|
|Principal Investigator: Claire Renaud, MD|
|Sub-Investigator: Laurent Brouchet, MD|
|Sub-Investigator: Solange Grunenwald, MD|
|Sub-Investigator: Philippe Caron, MD|
|Sub-Investigator: François Blain, MD|
|Sub-Investigator: Hervé Rousseau, MD|
|Principal Investigator:||Claire RENAUD||University Hospital, Toulouse|