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Not Yet RecruitingNCT06607133

Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules

Comparison of Staged Thermal Ablation and Thyroidectomy for Large Benign Thyroid Nodules

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Ming-an Yu · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

To compare the safety, efficacy and quality of life between staged thermal ablation and thyroidectomy in the treatment of Large benign thyroid nodules.

Detailed description

Large benign thyroid nodules (BTNs)usually cause compressive symptoms or cosmetic concerns and therefore require treatment. Thyroidectomy remains the mainstay treatment for large, symptomatic BTNs. However, if surgery is not feasible or refused, ablative approach could be considered in selected patients. However, it has been proved that single application of thermal ablation is less effective in causing shrinkage in large thyroid nodules. The possible reason is that it is difficult for single application of thermal ablation to cover all of the nodule tissue in a three-dimension if the nodule is large. In addition, nodule locations adjacent to vital structures might hinder complete treatment in one session because of safety concerns. Few studies reveal that staged thermal ablation (Pre-designed multiple sessions of thermal ablation) can also achieve complete ablation and adequate volume reduction of large benign thyroid nodules. However, there is a lack of comparison between these two methods. Thus, this study is aimed to compare the safety, efficacy, quality of life between staged thermal ablation and thyroidectomy for treating large benign thyroid nodules.

Conditions

Interventions

TypeNameDescription
PROCEDUREsurgerypatients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules
PROCEDUREstaged thermal ablationpatients undergo multiple sessions of thermal ablation for large benign thyroid nodules

Timeline

Start date
2024-09-10
Primary completion
2027-09-01
Completion
2027-12-01
First posted
2024-09-23
Last updated
2024-09-23

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06607133. Inclusion in this directory is not an endorsement.