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

NCT ID: NCT06506149

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-04
• Study Completion Date: 2026-06-30

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.

Conditions

Graves Disease; Minimally Invasive Treatment; Ablation Treatment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microwave ablation treatment

All participants will be treated by a device for USG-guided Microwave ablation treatment

Group Type: EXPERIMENTAL

Microwave ablation(MWA) device

Intervention Type: 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.

Interventions

Microwave 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Man Him Matrix Fung

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Yan Luk, MBBS

Role: CONTACT

floralukyan@gmail.com

+852 2255 4232

Facility Contacts

Man Him, Matrix Fung, MBBS

Role: primary

mmhfung@hku.hk

+852-22554232

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Other Identifiers

UW 23-343

Identifier Type: -

Identifier Source: org_study_id