Skip to main content
Clinical Trials/NCT06418919
NCT06418919
Active, not recruiting
Not Applicable

A Prospective Evaluation of Radiofrequency Ablation in the Treatment of Relapsed Graves' Disease.

The University of Hong Kong1 site in 1 country30 target enrollmentMarch 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Relapsed Graves' Disease
Sponsor
The University of Hong Kong
Enrollment
30
Locations
1
Primary Endpoint
Change in Quality of life
Status
Active, not recruiting
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
December 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Lang Hung Hin, Brian

Clinical Professor

The University of Hong Kong

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

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

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

Study Sites (1)

Loading locations...

Similar Trials