Radiofrequency Ablation in Thyroid Nodules

Not Applicable

• Conditions: Thyroid Nodules
• Interventions: Procedure: Radiofrequency ablation of the thyroid nodule

• Registration Number: NCT01750593
• Lead Sponsor: Bezmialem Vakif University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-07
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Study Start: 2013-04
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-11-28
• Primary Completion: 2014-01
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radiofrequency ablation of thyroid nodule	Radiofrequency ablation of the thyroid nodule	Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation

Primary Outcome Measures

Name	Time	Method
Shrinkage of the thyroid nodule after radiofrequency ablation	6 months

Secondary Outcome Measures

Name	Time	Method
Disappearance of the nodules in follow up	1 year

Trial Locations

Locations (2)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey

Bezmialem Vakif University medical Faculty; 🇹🇷 Istanbul, Turkey