Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426563
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-17
Brief Title:
MWA vs RFA for the Treatment of Moderate-sized Benign Thyroid Nodules
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Moderate-sized Benign Thyroid Nodules a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Thyroid nodule is a common condition that affects up to 60 of the population There is an estimated 10 lifetime probability of developing a thyroid nodule Although most thyroid nodules are benign up to 10-15 can enlarge to cause compressive symptoms including neck pressure and discomfort dysphagia dyspnea and dysphonia The conventional 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 Since the early 2000s ultrasound-guided percutaneous thermal ablation has emerged as a potential alternative treatment to surgery for benign thyroid nodules Of the myriad ablation methods the most commonly used techniques are radiofrequency ablation RFA and microwave ablation MWA 1-3 A growing body of evidence shows that RFA is an effective treatment for benign solid thyroid nodules toxic adenomas and thyroid cysts resulting in overall volume reduction ranges of 40-80 at 1 year with durable resolution of compressive and hyperthyroid symptoms However RFA is not without its limitations Radiofrequency waves can be limited by the heat sink effect and tissue char leading to longer procedure times and potentially less optimal outcomes in larger hypervascular andor more cystic nodules
Microwave ablation MWA is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect and therefore can facilitate more efficient ablation procedures Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective non-randomized 4-9 under-powered or with an unequal baseline The results from these studies were also conflicting suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies To date there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules Given the higher ablation temperatures freedom from heat sink effect and no influence from impedance changes during ablation MWA may achieve different treatment efficacy
Microwave ablation MWA is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect and therefore can facilitate more efficient ablation procedures Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective non-randomized 4-9 under-powered or with an unequal baseline The results from these studies were also conflicting suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies To date there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules Given the higher ablation temperatures freedom from heat sink effect and no influence from impedance changes during ablation MWA may achieve different treatment efficacy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None