Radiofrequency Ablation in Thyroid Nodules
Efficacy of Radiofrequency Ablation in Thyroid Nodules
1 other identifier
interventional
40
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 28, 2013
November 1, 2013
9 months
October 7, 2012
November 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Shrinkage of the thyroid nodule after radiofrequency ablation
6 months
Secondary Outcomes (1)
Disappearance of the nodules in follow up
1 year
Study Arms (1)
radiofrequency ablation of thyroid nodule
EXPERIMENTALUnder ultrasonography the thyroid nodules will be ablated by radiofrequency ablation
Interventions
Under USG control, the nodule will be ablated by radiofrequency with a needle that has an active tip of 1 cm.
Eligibility Criteria
You may qualify if:
- the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems;
- a poor surgical candidate or refusal to undergo surgery;
- fine-needle aspiration cytology and US findings that were compatible with a benign nodule;
- anxiety about a malignancy.
You may not qualify if:
- a nodule less than 5 mm in size;
- follicular neoplasm or malignancy on fine needle aspiration cytology (FNAC);
- a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although FNAC was a benign result;
- previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Bezmialem Vakif University
Istanbul, Istanbul, 34308, Turkey (Türkiye)
Bezmialem Vakif University medical Faculty
Istanbul, 34308, Turkey (Türkiye)
Bezmialem Vakif University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
October 7, 2012
First Posted
December 17, 2012
Study Start
April 1, 2013
Primary Completion
January 1, 2014
Study Completion
June 1, 2014
Last Updated
November 28, 2013
Record last verified: 2013-11