Efficacy of Radiofrequency Ablation in Thyroid Nodules
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Bezmialem Vakif University
- Enrollment
- 40
- Locations
- 5
- Primary Endpoint
- Shrinkage of the thyroid nodule after radiofrequency ablation
Study Overview
Brief Summary
Thyroid nodules are common problems and although > 95% are stated to be benign, they may cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with their function, size and localization. Especially for these nodules, patients undergo surgery and face up with the problems associated with surgical complications although they are not cancer. In some studies, radiofrequency ablation previously used for intrabdominal tumors like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid nodules and in some recurrent thyroid cancer cases. Therefore, the investigators decided to use this method in our patients having nodules like previously mentioned and see the efficacy and safety of the technique.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems;
- •a poor surgical candidate or refusal to undergo surgery;
- •fine-needle aspiration cytology and US findings that were compatible with a benign nodule;
- •anxiety about a malignancy.
Exclusion Criteria
- •a nodule less than 5 mm in size;
- •follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC);
- •a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result;
- •previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.
Arms & Interventions
radiofrequency ablation of thyroid nodule
Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation
Intervention: Radiofrequency ablation of the thyroid nodule (Procedure)
Outcomes
Primary Outcomes
Shrinkage of the thyroid nodule after radiofrequency ablation
Time Frame: 6 months
Secondary Outcomes
- Disappearance of the nodules in follow up(1 year)
Investigators
Yeliz Emine Ersoy
M.D.
Bezmialem Vakif University