A Prospective Evaluation of Microwave Ablation (MWA) in the Treatment of Relapsed Graves' Disease
NCT Number: NCT06506149
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Graves Disease|Minimally Invasive Treatment|Ablation Treatment
Interventions: DEVICE: Microwave ablation(MWA) device
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-07-04
Completion Date: 2026-06-30
Locations: Queen Mary Hospital, Hong Kong, 00000, Hong Kong

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.

Primary Outcome Measures: To measure the remission rate of Graves' disease at 6-months post-procedure, To measure the remission rate of Graves' disease at 6-months post-procedure, 6 months
Secondary Outcome Measures: Change of quality of life by SF12 ver 2, SF-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)., 6 months|To measure the percentage of volume change, the percentage of volume change would be calculated as: (\[Volbasal - Volfinal\] · 100)/Volbasal., 6 months