Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules

Ming-an Yu

Status

Not yet enrolling

Conditions

Benign Thyroid Nodules

Treatments

Procedure: staged thermal ablation

Procedure: surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06607133

S2019-283-02

Details and patient eligibility

About

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

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

benign thyroid nodules confirmed by surgical pathology in surgery group, and by two separate US-guided fine-needle aspiration (FNA) or core needle biopsy (CNB) in thermal ablation group;
the largest diameter of the nodule ≥4 cm;
the presence of nodule-related symptoms, cosmetic concerns, or psychological stress;
patients treated with surgery, or staged thermal ablation (who explicitly refused surgery);
more than 12-month follow-up duration

Exclusion criteria

suspicion of malignant nodule on ultrasound findings (e.g., marked hypoechoic, microcalcifications, or ill-defined margins);
comorbidities of other severe diseases;
without complete treatment and/or follow-up information