RFA (Radiofrequency Ablation) Versus EA (Ethanol Ablation) for Predominantly Cystic Thyroid Nodules

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Jung Hwan Baek, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01778400
First received: January 25, 2013
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

Ultrasound-guided ethanol ablation is an effective treatment modality for patients with cystic thyroid nodules (cystic portion > 90%); however it is less effective in predominantly cystic thyroid nodules (90% > cystic portions > 50%). The volume reduction after EA has been reported 64% - 69.8% for predominantly cystic thyroid nodules. EA is insufficient for 26% (27/103) of patients with predominantly cystic thyroid nodules. Radiofrequency ablation to patients with incompletely resolved clinical problems after EA and the mean volume reduction ratio was 92% at 6-month follow-up. It is well known that RF ablation is effective in both predominantly cystic and solid thyroid nodules. Although RF ablation has effectively treated the patients who were unsatisfactory after EA, to the best of our knowledge, no study to date has compared these two ablation techniques. Therefore investigators performed a prospective randomized study to compare single-session RF ablation and EA for treating predominantly cystic thyroid nodules.


Condition Intervention
Thyroid Nodule
Procedure: radiofrequency ablation
Procedure: Ethanol ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Session Treatment of RFA Versus EA for Predominantly Cystic Thyroid Nodules: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • quantitative volume reduction ratio of a thyroid lesion at six months following compared with before the ablation treatment [ Time Frame: at six months following compared with before the ablation treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • binary therapeutic success rate which was defined as the proportion of patients who showed volume reduction >50%, improvement of symptomatic and cosmetic scores, and the number of major complications [ Time Frame: 6-month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiofrequency ablation
Treatment with radiofrequency ablation for the thyroid lesions and compare the results with ethanol ablation in terms of volume reduction at 6-month follow-up (primary end point).
Procedure: radiofrequency ablation
radiofrequency ablation for the treatment as a new therapy as compared with ethanol ablation as a conventional therapy
Active Comparator: Ethanol
Treatment of predominantly cystic nodule with ethanol ablation and compare these results to radiofrequency ablation in terms of volume reduction at 6-month follow-up.
Procedure: Ethanol ablation
ethanol ablation as a conventional/control therapy to be compared with a new experimental therapy--radiofrequency ablation

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with predominantly cystic thyroid nodules (90% > cystic portion > 50%)
  • reports of pressure symptoms or cosmetic problems
  • cytologic confirmation of benignancy in at least two, separate US-guided, fine-needle aspiration cytology or core needle biopsy for cystic fluid and/or a mural, solid component
  • serum levels of thyroid hormone, thyrotropin, and calcitonin within normal limits.

Exclusion Criteria:

  • nodules showing malignant features, i.e. taller than wide, spiculated margin, markedly hypoechoic, micro- or macrocalcifications, on US
  • lack of informed consent
  • less than 20 years old
  • pregnant woman
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778400

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Study Chair: Jung Hwan Baek, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Jung Hwan Baek, Associate professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01778400     History of Changes
Other Study ID Numbers: BJH_PCYST
Study First Received: January 25, 2013
Last Updated: November 7, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Ultrasound
Radiofrequency
Ethanol
Predominantly cystic thyroid nodule
Thyroid nodule
Thyroid

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014