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A Prospective Evaluation of Microwave Ablation (MWA) in the Treatment of Relapsed Graves' Disease

A Prospective Evaluation of Microwave Ablation (MWA) in the Treatment of Relapsed Graves' Disease

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06506149
Enrollment
25
Registered
2024-07-17
Start date
2023-07-04
Completion date
2026-06-30
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ablation Treatment, Graves Disease, Minimally Invasive Treatment

Keywords

Graves disease, Thyroid function, remission, non surgical

Brief summary

Graves' disease is the most common cause of hyperthyroidism, with conventional treatment options being anti-thyroid drugs (ATD), radioiodine (RAI) and surgery. For ATD, it has been the first-line treatment over decades. Despite its ability to induce remission, minor side effects such as skin rash, gastrointestinal disturbance and arthralgia occur in around 5% of patients, while serious adverse reactions including agranulocytosis and hepatotoxicity are potentially life threatening. Patients are usually treated with ATD for 12 to 18 months but the relapse rate was reported to be up to 50-60% which these patients would require more definitive treatment options with RAI or thyroidectomy. However, RAI is not preferable in patients with Graves' ophthalmopathy as it could further worsen eye symptoms. RAI may also cause hypothyroidism in a substantial proportion of patients, with a subsequent need for lifelong thyroxine replacement. As for thyroidectomy, it carries an overall 2-10% risk of complications including bleeding, transient or permanent recurrent laryngeal nerve injury and hypoparathyroidism. Due to the drawbacks of the various conventional treatment options, there has been increasing interest in the development of minimally invasive treatment alternatives in recent years. With the evolution of thermal ablative strategies, high-intensity focused ultrasound (HIFU) and radiofrequency ablation (RFA) have been reported as feasible treatment options for relapsed Graves' disease. There has also been increasing reports in the use of microwave ablation (MWA) in the treatment of benign thyroid nodules. MWA works via generation of electromagnetic field and is performed by inserting a microwave antenna into the thyroid gland percutaneously under ultrasound (USG) guidance. The active tip of the antenna causes oscillation of the surrounding water molecules which induces frictional heat and creates a thermal ablative effect. As compared to RFA, MWA is not affected by heat sink effect and may require a shorter treatment time. Similar to other thermal ablative approaches, MWA has the merits of avoiding surgical scar, organ preservation as well as being an ambulatory procedure.

Interventions

DEVICEMicrowave ablation(MWA) device

The device for USG-guided MWA treatment would be performed under USG guidance, aiming to ablate the entire thyroid gland, i.e. the right lobe, left lobe, isthmus and pyramidal lobe.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Consecutive patients with relapsed Graves' disease will be considered for microwave ablation treatment

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 * (c) absence of vocal cord immobility

Exclusion criteria

* (a) patients who prefer or are indicated for surgery, * (b) presence of head and/or neck disease preventing hyperextension of the neck, * (c) history of thyroid cancer or other malignant tumours in the neck region, * (d) history of neck irradiation, * (e) severe Graves' ophthalmopathy, * (f) large compressive goitre, * (g) pregnancy or lactation, and * (h) any contraindication to intravenous sedation.

Design outcomes

Primary

MeasureTime frameDescription
To measure the remission rate of Graves' disease at 6-months post-procedure6 monthsTo measure the remission rate of Graves' disease at 6-months post-procedure

Secondary

MeasureTime frameDescription
Change of quality of life by SF12 ver 26 monthsSF-12(v2) is an assessment tool about quality of life. It comprises 12 question items ranging from 11 (worst quality of life) to 56 (best quality of life).
To measure the percentage of volume change6 monthsthe percentage of volume change would be calculated as: (\[Volbasal - Volfinal\] · 100)/Volbasal.

Countries

Hong Kong

Contacts

Primary ContactYan Luk, MBBS
floralukyan@gmail.com+852 2255 4232

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026