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

Thyroid; Functional Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06418919
• Other study ID #: UW 22-504
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2024
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Graves Disease
• Thyroid; Functional Disturbance

Intervention

Procedure:
• Radiofrequency ablation treatment
RFA is used to ablate the entire thyroid gland

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (8)

Cooper DS. Antithyroid drugs. N Engl J Med. 2005 Mar 3;352(9):905-17. doi: 10.1056/NEJMra042972. No abstract available. — View Citation

Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14. — View Citation

Kuo JH, Lee JA. The Adoption of Ultrasound-guided Radiofrequency Ablation of Thyroid Nodules in the United States. Ann Surg. 2021 Jan 1;273(1):e10-e12. doi: 10.1097/SLA.0000000000003930. No abstract available. — View Citation

Lang BH, Woo YC, Chiu KW. Two-year outcomes of single-session high-intensity focused ultrasound (HIFU) treatment in persistent or relapsed Graves' disease. Eur Radiol. 2019 Dec;29(12):6690-6698. doi: 10.1007/s00330-019-06303-8. Epub 2019 Jun 17. — View Citation

Lang BH, Woo YC, Wong IY, Chiu KW. Single-Session High-Intensity Focused Ultrasound Treatment for Persistent or Relapsed Graves Disease: Preliminary Experience in a Prospective Study. Radiology. 2017 Dec;285(3):1011-1022. doi: 10.1148/radiol.2017162776. Epub 2017 Jul 20. — View Citation

Papini E, Pacella CM, Solbiati LA, Achille G, Barbaro D, Bernardi S, Cantisani V, Cesareo R, Chiti A, Cozzaglio L, Crescenzi A, De Cobelli F, Deandrea M, Fugazzola L, Gambelunghe G, Garberoglio R, Giugliano G, Luzi L, Negro R, Persani L, Raggiunti B, Sardanelli F, Seregni E, Sollini M, Spiezia S, Stacul F, Van Doorne D, Sconfienza LM, Mauri G. Minimally-invasive treatments for benign thyroid nodules: a Delphi-based consensus statement from the Italian minimally-invasive treatments of the thyroid (MITT) group. Int J Hyperthermia. 2019;36(1):376-382. doi: 10.1080/02656736.2019.1575482. Epub 2019 Mar 26. — View Citation

Watanabe N, Narimatsu H, Noh JY, Yamaguchi T, Kobayashi K, Kami M, Kunii Y, Mukasa K, Ito K, Ito K. Antithyroid drug-induced hematopoietic damage: a retrospective cohort study of agranulocytosis and pancytopenia involving 50,385 patients with Graves' disease. J Clin Endocrinol Metab. 2012 Jan;97(1):E49-53. doi: 10.1210/jc.2011-2221. Epub 2011 Nov 2. — View Citation

Yip J, Lang BH, Lo CY. Changing trend in surgical indication and management for Graves' disease. Am J Surg. 2012 Feb;203(2):162-7. doi: 10.1016/j.amjsurg.2011.01.029. Epub 2011 Jun 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term disease remission rate after a single course of RFA	Graves' disease remission rate after a single course of RFA	12 months
Primary	Mid term remission rate after a single course of RFA	Graves' disease remission after a single course of RFA	24 months and 36 months
Primary	Complication rates	To measure the complication rates after RFA	1 month
Primary	Change in Quality of life	To examine the change in qualitfy of life with SF-12 scores in post-treatment from baseline to 24 months and 36 months	24 months, 36 months

External Links

•   Ultrasound-guided percutaneous radiofrequency ablation for benign thyroid nodules