Radiofrequency Ablation in Thyroid Nodules

Thyroid Nodules Clinical Trial

Official title:

Efficacy of Radiofrequency Ablation in Thyroid Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01750593
• Other study ID #: yelizeminersoy
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2012
• Last updated: November 27, 2013
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2013
• Source: Bezmialem Vakif University
• Contact: Erhan Aysan, Prof. Dr.
• Email: erhanaysan[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule
• Thyroid Nodules

Intervention

Procedure:
• Radiofrequency ablation of the thyroid nodule
Under USG control, the nodule will be ablated by radiofrequency with a needle that has an active tip of 1 cm.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul
Turkey	Bezmialem Vakif University	Istanbul
Turkey	Bezmialem Vakif University medical Faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shrinkage of the thyroid nodule after radiofrequency ablation		6 months	No
Secondary	Disappearance of the nodules in follow up		1 year	No