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NCT07804862
Efficacy and Safety of RFA vs MWA for Treatment of Large Benign Thyroid Nodules, RCT
Conditions: Ablation Techniques, RFA, Ablation Treatment, Benign Thyroid Nodules, Local Anaesthesia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: The University of Hong Kong
Location: Queen Mary Hospital 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.
Eligibility Criteria
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
* indeterminate nodules classified benign
* nodules with substernal extension or posterior extension that cannot be viewed sufficiently with ultrasound
* current pregnancy or cardiac arrhythmias
Source: ClinicalTrials.gov (NCT07804862). StuddyBuddy aggregates publicly available trial information.