RFA (Radiofrequency Ablation) Versus EA (Ethanol Ablation) for Predominantly Cystic Thyroid Nodules
This study is currently recruiting participants.
Verified February 2013 by Asan Medical Center
Sponsor:
Asan Medical Center
Information provided by (Responsible Party):
Jung Hwan Baek, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01778400
First received: January 25, 2013
Last updated: February 14, 2013
Last verified: February 2013
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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:
MedlinePlus related topics:
Thyroid Diseases
Drug Information available for:
Thyroid
U.S. FDA Resources
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: | March 2014 |
| Estimated Primary Completion Date: | February 2014 (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
Contacts
| Contact: Dokyung Kim | 82-2-3010-9522 | kdk0720@amc.seoul.kr |
Locations
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Jung Hwan Baek, MD 82-2-3010-4348 radbaek@naver.com | |
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: | February 14, 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 May 16, 2013