Comparing the Efficacy and Safety of Radiofrequency Ablation Versus Microwave Ablation for the Treatment of Large Benign Thyroid Nodules, a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Volume reduction rate (VRR) of thyroid nodule at 6 months (%)
Study Overview
Brief Summary
We conduct a multi-institutional randomized control trial of RFA and MWA for the primary treatment of large, benign nodules. Adult patients >/=18 years of age who have a solitary thyroid nodule ≥20ml in volume who presents to 1) Columbia University, NY or 2) Queen Mary Hospital, Hong Kong for consultation will be eligible for enrollment in the study. They will need either a) two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or b) one benign fine needle biopsy and low suspicion characteristics on ultrasound. Both functional and non-functional nodules are eligible.
Patients will be randomly assigned to either treatment arm a) RFA or treatment arm b) MWA according to a pre-generated block randomization list.
Detailed Description
Benign thyroid nodules can cause compressive symptoms for patients, including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. Some nodules will become autonomously functioning causing hyperthyroidism. Traditionally the gold standard treatment for these benign, but problematic nodules, has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation.
Introduced in the early 2000s, ultrasound-guided percutaneous ablation of thyroid lesions has emerged as a potential alternative to surgery in patients with benign thyroid nodules. Of the myriad ablation methods, the most commonly used technique are radiofrequency ablation (RFA) and microwave ablation (MWA). The two techniques used different mechanisms for heat generation.
Current evidence comparing RFA versus MWA for thyroid ablation were limited and were either retrospective or non-randomized, with focus mainly on small thyroid nodules of ≤10ml in volume. There is a lack of high quality evidence on the safety and efficacy of RFA versus MWA for the treatment of large thyroid nodules (≥20ml).
The aim of this randomized controlled trial is to compare the safety and efficacy of RFA and MWA in the treatment of large, benign thyroid nodules.
The primary outcome of is the volume reduction rate at 6 months after ablation. The secondary outcomes include safety, complication rates and quality of life after both procedures.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •who have a solitary thyroid nodule ≥20ml in volume
- •two benign fine needle biopsies, with the most recent biopsy performed within 1 year of enrollment in study or one benign fine needle biopsy and low suspicion characteristics on ultrasound
- •Both functional and non-functional nodules are eligible
Exclusion Criteria
- •have multiple nodules and planned simultaneous ablation
- •cytologically indeterminate thyroid nodules
- •nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound
- •current pregnancy or cardiac arrhythmias
Arms & Interventions
Microwave ablation
Apply microwave ablation to those large benign thyroid nodules for shrinkage purpose
Intervention: Microwave ablation (Device)
Radiofrequency ablation
Apply radiofrequency ablation to those large benign thyroid nodules for shrinkage purpose
Intervention: Radiofrequency ablation alone (Device)
Outcomes
Primary Outcomes
Volume reduction rate (VRR) of thyroid nodule at 6 months (%)
Time Frame: 6 months
To measure the volume reduction rate (VRR) of thyroid nodule at 6-month. volume of nodule= length(cm) x width(cm) x depth(cm) x (π / 6 ) VRR = \[(volume at baseline - volume at 6-month)/volume of baseline\] x 100%
Secondary Outcomes
- Changes in compressive symptom scores (0-100)(12 months)
- Changes in cosmetic symptom scores (1-4)(12 months)
- Peri-operative pain scores (0-10)(12 months)
- Volume reduction rate (VRR) of thyroid nodule at 12 months (%)(12-months)
- Complications from procedure including vocal cord palsy, bleeding, infection, nodule rupture, skin burn(12 months)
Investigators
Man Him Matrix Fung
Clinical Assistant Professor
The University of Hong Kong