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

NCT ID: NCT06418919

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed Graves' Disease Thyroid; Functional Disturbance Radiofrequency Ablation Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RFA treatment

Group Type EXPERIMENTAL

Radiofrequency ablation treatment

Intervention Type PROCEDURE

RFA is used to ablate the entire thyroid gland

Interventions

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Radiofrequency ablation treatment

RFA is used to ablate the entire thyroid gland

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Lang Hung Hin, Brian

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matrix, Man Him Fung, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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

Reference Type BACKGROUND
PMID: 15745981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22049174 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21683939 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31209622 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28727542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29962870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33064390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30909759 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38836419 (View on PubMed)

Related Links

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http://www.nice.org.uk/guidance/ipg562

Ultrasound-guided percutaneous radiofrequency ablation for benign thyroid nodules

Other Identifiers

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UW 22-504

Identifier Type: -

Identifier Source: org_study_id

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