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

NCT06418919 | Active Not Recruiting DMC

• 1 other identifier: UW 22-504
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed Graves' Disease; Thyroid; Functional Disturbance; Radiofrequency Ablation Treatment

Outcome Measures

Primary Outcomes (4)

• Short term disease remission rate after a single course of RFA

  Graves' disease remission rate after a single course of RFA

  12 months

• Mid term remission rate after a single course of RFA

  Graves' disease remission after a single course of RFA

  24 months and 36 months

• Complication rates

  To measure the complication rates after RFA

  1 month

• 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

Study Arms (1)

RFA treatment

EXPERIMENTAL

Procedure: Radiofrequency ablation treatment

Interventions

Radiofrequency ablation treatment PROCEDURE

RFA is used to ablate the entire thyroid gland

RFA treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (9)

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

  PMID: 15745981 BACKGROUND

• 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.

  PMID: 22049174 BACKGROUND

• 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.

  PMID: 21683939 BACKGROUND

• 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.

  PMID: 31209622 BACKGROUND

• 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.

  PMID: 28727542 BACKGROUND

• 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.

  PMID: 29962870 BACKGROUND

• 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.

  PMID: 33064390 BACKGROUND

• 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.

  PMID: 30909759 BACKGROUND

• Fung MHM, Luk Y, Yuen KKW, Lang BHH. The Two-Year Results of Using Radiofrequency Ablation as a Novel Treatment for Persistent or Relapsed Graves' Disease: A Prospective Study. Thyroid. 2024 Aug;34(8):1017-1026. doi: 10.1089/thy.2024.0177. Epub 2024 Jul 3.

  PMID: 38836419 DERIVED

Related Links

• Ultrasound-guided percutaneous radiofrequency ablation for benign thyroid nodules

MeSH Terms

Conditions

Graves Disease; Thyroid Diseases

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Matrix, Man Him Fung, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 17, 2024
• Study Start: March 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

HK (1)