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Efficacy and Safety of RFA vs MWA for Treatment of Large Benign Thyroid Nodules, RCT
Sponsor: The University of Hong Kong
Summary
We will 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. After thorough evaluation of each individual case and if the eligibility criteria are met, participants will be offered ultrasound guided thermal ablation as a viable option for management of their nodule. If they consent to undergo thermal ablation and consent to participation in the study, patients will be randomly assigned to either treatment arm a) RFA or treatment arm b) MWA according to a pre-generated block randomization list created using www.sealedenvelope.com.
Official title: Comparing the Efficacy and Safety of Radiofrequency Ablation Versus Microwave Ablation for the Treatment of Large Benign Thyroid Nodules, a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2023-12-05
Completion Date
2027-06-30
Last Updated
2026-09-04
Healthy Volunteers
No
Interventions
Radiofrequency ablation alone
Ultrasound-guided thermal ablation will be performed using STARmed internally cooled RFA electrodes (18 gauge) powered by the VIVA RF generator in accordance with the 'moving shot' technique described by Baek et al. The RFA procedure uses image guidance to place an electrode through the skin into the target area. In RFA, high frequency electrical currents are passed through an electrode, creating a small region of heat to treat the lesion.
Microwave ablation
Ultrasound-guided thermal ablation will be performed using ECO Medical internally cooled MWA antennas (16 or 17 gauge) powered by the ECO Medical generator in accordance with the 'moving shot' technique described by Baek et al. The MWA procedure uses image guidance to place an electrode through the skin into the target area. In MWA, high frequency electromagnetic waves are passed through an electrode, creating a small region of heat to treat the lesion.
Locations (1)
Queen Mary Hospital
Hong Kong, Hong Kong