US-guided Radiofrequency Ablation Versus Microwave Ablation in the Treatment of Benign Thyroid Nodules
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 50
- Primary Endpoint
- thyroid nodule volume reduction
Study Overview
Brief Summary
To evaluate the clinical outcomes of RFA and MWA for benign thyroid nodules treatment
Detailed Description
The thyroid nodule is one of the most common lesions in clinical practice and has been increasingly detected in approximately 50% of the general population by ultrasound (US) examination in the past two decades due to the widespread use of radiological imaging.
Benign thyroid nodules (BTNs) proven cytologically by fine-needle aspiration biopsy (FNAB) account for 85 to 95% of all thyroid nodules.
Despite the fact that the majority of thyroid nodules diagnosed are benign and do not cause significant clinical symptoms, some nodules may lead to compression-related symptoms. In addition, thyrotoxic symptoms may develop due to hyperfunctioning of some nodules.
To date, surgical resection is the main treatment for thyroid nodules. However, it has serious drawbacks such as leading to excessive surgical trauma or hypothyroidism, influencing the aesthetic aspect of the neck, or increasing a post-operative recurrence rate.
RFA has shown good efficacy and safety in the management of thyroid nodule related cosmetic problems and pressure symptoms.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Solid or mixed nodules with predominant solid component with benign pathological result from US guided fine needle aspiration (FNAC).
- •Symptomatic and/or cosmetic problems.
- •Clinical thyrotoxicosis and hyperthyroidism caused by autonomously functioning thyroid nodules (AFTNs)
- •Refusal or ineligible for surgery.
- •Anxiety about a malignant transformation.
Exclusion Criteria
- •Malignant nodules on US.
- •Cytological evidence for malignancy
- •Patients with abnormal coagulation profile.
- •previous surgery or medicine for the thyroid, and vocal cord palsy in the side contralateral to the target nodules.
Outcomes
Primary Outcomes
thyroid nodule volume reduction
Time Frame: 2 years
volume reduction ratio VRR assessed by Ultrasound = \[(initial volume - final volume)/initial volume\] x 100.
cosmetic score
Time Frame: 2 years
cosmetic score will be measured by the physician (1, no palpable mass; 2, no cosmetic problem but palpable mass; 3, a cosmetic problem on swallowing only; and 4, a readily detected cosmetic problem) 1 indicates the best outcome and 4 indicates the worst outcome
symptoms score
Time Frame: 2 years
symptoms score will be assessed by (visual analogue scale) a score from 1 to 10 will be given by the patient according to each symptom including (neck pain , dysphagia , foreign body sensation , discomfort and cough) 1 is the minimum score indicating the best outcome and 10 is the maximum score indicating worst outcome
Secondary Outcomes
No secondary outcomes reported
Investigators
Omar Gamal Mokhtar
Assistant Lecturer
Assiut University