Overview
The goal of this clinical trial is to learn if microwave ablation of benign thyroid nodules under local anaesthesia is a safe and effective procedure compared to open thyroidectomy.
The main questions it aims to answer are:
Dose microwave Ablation effectively cause shrinkage of thyroid nodules? Can ablation of selective area of nodules be safely performed under ultrasound guidance, avoiding critical structures including recurrent laryngeal nerve, major vessels and trachea? Researchers will recruit subjects with symptomatic benign thyroid nodules for Microwave Ablation.
Participants will:
Undergo ultrasound guided Microwave Ablation of benign thyroid nodules. Visit the clinic at post operation 2-week, 3-month, 6-month, 12-month, 2-year and 3-year for checkups and tests.
Fill in questionnaire at each clinic visit for pain, pressure symptoms, cosmetic overall satisfaction in Visual Analog Scale.
Description
Benign thyroid nodules are common in the general population. Some of them can cause significant patient concerns including compression symptoms and cosmetic issues. Traditional treatment of symptomatic benign thyroid nodules has been surgical excision which is a procedure under general anaesthesia and carries peri-operative complications. Microwave ablation (MWA) is a minimally invasive procedure, which is used for benign and malignant tumors of liver and lung. It has gained attention among otolaryngologists as it could be a minimally invasive procedure under local anaesthesia and effectively causes shrinkage of thyroid nodules, according to some recent studies. Ablation of selective area of nodules can be safely performed under ultrasound guidance, avoiding critical structures including recurrent laryngeal nerve, major vessels and trachea. Effect of ablation could also be 'visualized' real time with ultrasound images.
This is a prospective study. There is one arm, Microwave Ablation of thyroid nodules. We will recruit 60 subjects with symptomatic benign thyroid nodules for Microwave Ablation.
Under ultrasound guidance, the microwave electrode was inserted targeted to the nodule. The extent of the ablated zone is determined real-time by the echogenic changes around the electrode. Ablation will be away from important structure, including major vessels, recurrent laryngeal nerve and trachea.
Participants will have clinic visit at post operation 2-week 3-month, 6-month, 12-month, 2-year and 3-year for checkups and tests.
Eligibility
Inclusion Criteria:
- Thyroid nodules or dominant nodule of multinodular goitre
- Symptomatic thyroid nodule not less than 2cm
- Benign thyroid nodule confirmed by Fine needle aspiration for cytology (FNAC)
Exclusion Criteria:
- Asymptomatic thyroid nodule
- Malignant thyroid nodule
- High risk USG features or cytological features
- Previous anterior neck surgery
- Previous radiotherapy at the head and neck region
- Presence of another malignancy, lateral neck, or distant metastasis
- Cervical spine disease precluding extension of the neck
- Patients under 18 years old
- Vulnerable population (e.g. Cognitive impairment, pregnancy)
- Obesity with BMI \> 35kg/m2
- Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- Non-correctable coagulopathy
