A Prospective Evaluation of Radiofrequency Ablation in the Treatment of Relapsed Graves' Disease.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mid term remission rate after a single course of RFA
Study Overview
Brief Summary
There have been previous reports of using High-intensity focused ultrasound (HIFU) as a feasible thermal ablative treatment for relapsed Graves' disease. In recent years, radiofrequency ablation (RFA) has become another promising alternative for thermal ablation of benign thyroid nodules. RFA has the advantage of avoiding a surgical scar, organ preservation and being an ambulatory procedure. It utilizes a small caliber radiofrequency electrode, which is inserted into the thyroid gland percutaneously. The active tip of the RF electrode would induce frictional heat in the surrounding tissue, causing a thermal ablative effect. The direct application of energy of RFA to tissue is different from that in HIFU, in which energy is transmitted through the skin of the participants from the transducer.
Studies of follow-up after RFA of Graves' disease have not been published. Given the previous successful experience with HIFU, the investigators would like to explore the feasibility, safety and efficacy of RFA as an alternative thermal ablation option for relapsed Graves' disease. Thus, the purpose of this prospective study is to assess the efficacy and safety of US-guided RFA for the treatment of relapsed Graves' disease.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(a) age older than 18 years,
- •(b) relapsed Graves' disease despite an adequate ATD treatment for 18 months or more and
- •(c) absence of vocal cord immobility.
Exclusion Criteria
- •(a) patients who prefer or indicated for surgery,
- •(b) head and/or neck disease preventing hyperextension of the neck,
- •(c) history of thyroid cancer or other malignant tumors in the neck region,
- •(d) history of neck irradiation,
- •(e) moderate to severe Graves' ophthalmopatty,
- •(f) large compressive goiter
- •(g) pregnancy or lactation, and
- •(h) any contraindication related to intravenous moderate sedation.
Arms & Interventions
RFA treatment
Intervention: Radiofrequency ablation treatment (Procedure)
Outcomes
Primary Outcomes
Mid term remission rate after a single course of RFA
Time Frame: 24 months and 36 months
Graves' disease remission after a single course of RFA
Complication rates
Time Frame: 1 month
To measure the complication rates after RFA
Change in Quality of life
Time Frame: 24 months, 36 months
To examine the change in qualitfy of life with SF-12 scores in post-treatment from baseline to 24 months and 36 months
Short term disease remission rate after a single course of RFA
Time Frame: 12 months
Graves' disease remission rate after a single course of RFA
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Lang Hung Hin, Brian
Clinical Professor
The University of Hong Kong