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

Not Applicable

Recruiting

• Conditions: Minimally Invasive Treatment; Graves Disease; Ablation Treatment
• Interventions: Device: Microwave ablation(MWA) device

• Registration Number: NCT06506149
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-04
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microwave ablation treatment	Microwave ablation(MWA) device	All participants will be treated by a device for USG-guided Microwave ablation treatment

Primary Outcome Measures

Name	Time	Method
To measure the remission rate of Graves' disease at 6-months post-procedure	6 months	To measure the remission rate of Graves' disease at 6-months post-procedure

Secondary Outcome Measures

Name	Time	Method
Change of quality of life by SF12 ver 2	6 months	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).
To measure the percentage of volume change	6 months	the percentage of volume change would be calculated as: (\[Volbasal - Volfinal\] · 100)/Volbasal.

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong