NCT01778400

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 11, 2013

Status Verified

November 1, 2013

Enrollment Period

3 months

First QC Date

January 25, 2013

Last Update Submit

November 7, 2013

Conditions

Thyroid Nodule

Keywords

UltrasoundRadiofrequencyEthanolPredominantly cystic thyroid noduleThyroid noduleThyroid

Outcome Measures

Primary Outcomes (1)

  • quantitative volume reduction ratio of a thyroid lesion at six months following compared with before the ablation treatment

    at six months following compared with before the ablation treatment

Secondary Outcomes (1)

  • 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

    6-month

Study Arms (2)

Radiofrequency ablation

EXPERIMENTAL

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

Ethanol

ACTIVE COMPARATOR

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

Interventions

radiofrequency ablationPROCEDURE

radiofrequency ablation for the treatment as a new therapy as compared with ethanol ablation as a conventional therapy

Radiofrequency ablation
Ethanol ablationPROCEDURE

ethanol ablation as a conventional/control therapy to be compared with a new experimental therapy--radiofrequency ablation

Ethanol

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Thyroid NoduleThyroid Diseases

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Jung Hwan Baek, MD

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2013

Study Completion

January 1, 2014

Last Updated

November 11, 2013

Record last verified: 2013-11

Locations

KR(1)