Radiofrequency Ablation in Thyroid Nodules

November 27, 2013 updated by: Yeliz Emine Ersoy, Bezmialem Vakif University

Efficacy of Radiofrequency Ablation in Thyroid Nodules

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Bezmialem Vakif University
        • Contact:
      • Istanbul, Turkey, 34308
        • Recruiting
        • Bezmialem Vakif University medical Faculty
        • Contact:
      • Istanbul, Turkey, 34308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: radiofrequency ablation of thyroid nodule
Under ultrasonography the thyroid nodules will be ablated by radiofrequency ablation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Shrinkage of the thyroid nodule after radiofrequency ablation
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disappearance of the nodules in follow up
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

October 7, 2012

First Submitted That Met QC Criteria

December 13, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yelizeminersoy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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