Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules

NCT ID: NCT06607133

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2027-12-31

Brief 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

Benign Thyroid Nodules

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

surgery group

patients treated with thyroidectomy for benign thyroid nodules

surgery

Intervention Type: PROCEDURE

patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules

thermal ablation group

patients treated with staged thermal ablation for benign thyroid nodules

staged thermal ablation

Intervention Type: PROCEDURE

patients undergo multiple sessions of thermal ablation for large benign thyroid nodules

Interventions

surgery

patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules

Intervention Type: PROCEDURE

staged thermal ablation

patients undergo multiple sessions of thermal ablation for large benign thyroid nodules

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ming-an Yu

OTHER

Sponsor Role: lead

Responsible Party

Ming-an Yu

Head of the Department of Interventional Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Ming-an Yu, MD

Role: CONTACT

yma301@163.com

86-84205756

Other Identifiers

S2019-283-02

Identifier Type: -

Identifier Source: org_study_id