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Radiofrequency Ablation in Thyroid Nodules

B

Bezmialem Vakif University

Status

Unknown

Conditions

Thyroid Nodules

Treatments

Procedure: Radiofrequency ablation of the thyroid nodule

Study type

Interventional

Funder types

Other

Identifiers

NCT01750593
yelizeminersoy

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems;
  2. a poor surgical candidate or refusal to undergo surgery;
  3. fine-needle aspiration cytology and US findings that were compatible with a benign nodule;
  4. anxiety about a malignancy.

Exclusion criteria

  1. a nodule less than 5 mm in size;
  2. follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC);
  3. a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result;
  4. previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

radiofrequency ablation of thyroid nodule
Experimental group
Description:
Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation
Treatment:
Procedure: Radiofrequency ablation of the thyroid nodule

Trial contacts and locations

3

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Central trial contact

Erhan Aysan, Prof. Dr.; Yeliz Ersoy, Assoc.Prof

Data sourced from clinicaltrials.gov

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