Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: surgery, staged thermal ablation.
- Who it may be relevant to
- Registry conditions: Benign Thyroid Nodules. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Staged Thermal Ablation and Thyroidectomy for Large Benign Thyroid Nodules
Overview
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.
Interventions
- Procedure surgery
patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules - Procedure staged thermal ablation
patients undergo multiple sessions of thermal ablation for large benign thyroid nodules
Primary outcome measures
- volume reduction ratio [Time frame: From enrollment to the end of treatment at 12 months]
- Complications [Time frame: From enrollment to the end of treatment at 12 months]
Secondary outcome measures (2)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [Time frame: From enrollment to the end of treatment at 12 months]
- Thyroid Cancer-Specific Quality of Life questionnaire [Time frame: From enrollment to the end of treatment at 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- China-Japan Friendship Hospital — Beijing
Identifiers
NCT: NCT06607133 · S2019-283-02