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Radiofrequency Ablation in Thyroid Nodules

This study is not yet open for participant recruitment.
Verified December 2012 by Bezmialem Vakif University
Sponsor:
Information provided by (Responsible Party):
Yeliz Emine Ersoy, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT01750593
First received: October 7, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Thyroid Nodules
 Procedure: Radiofrequency ablation of the thyroid nodule

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Radiofrequency Ablation in Thyroid Nodules

Resource links provided by NLM:

Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Bezmialem Vakif University:

Primary Outcome Measures:
  • Shrinkage of the thyroid nodule after radiofrequency ablation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disappearance of the nodules in follow up [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750593

Contacts
Contact: Erhan Aysan, Prof. Dr. erhanaysan@hotmail.com

Locations
Turkey
Bezmialem Vakif University medical Faculty Not yet recruiting
Istanbul, Turkey, 34308
Contact: Erhan Aysan, Prof. Dr.         erhanaysan@hotmail.com    
Sponsors and Collaborators
Bezmialem Vakif University
  More Information

No publications provided

Responsible Party: Yeliz Emine Ersoy, M.D., Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01750593     History of Changes
Other Study ID Numbers: yelizeminersoy
Study First Received: October 7, 2012
Last Updated: December 13, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Bezmialem Vakif University:
radiofrequency
thyroid
nodule

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
 Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013