Clinical trial NCT06607133: Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules
Official title: Comparison of Staged Thermal Ablation and Thyroidectomy for Large Benign Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Benign Thyroid Nodules
Keywords: thermal ablation
Thyroidectomy
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with surgery, or staged thermal ablation in China-Japan Friendship Hospital

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.

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

Primary outcomes:
measure: volume reduction ratio
timeFrame: From enrollment to the end of treatment at 12 months
measure: Complications
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
timeFrame: From enrollment to the end of treatment at 12 months
measure: Thyroid Cancer-Specific Quality of Life questionnaire
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: