Thermal Ablation Vs Thyroidectomy for Large Benign Thyroid Nodules

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура surgery
  patients undergo conventional/open thyroidectomy or endoscopic thyroidectomy for large benign thyroid nodules
• Процедура staged thermal ablation
  patients undergo multiple sessions of thermal ablation for large benign thyroid nodules

Первичные конечные точки

• volume reduction ratio [Срок оценки: From enrollment to the end of treatment at 12 months]
• Complications [Срок оценки: From enrollment to the end of treatment at 12 months]

Вторичные конечные точки (2)

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [Срок оценки: From enrollment to the end of treatment at 12 months]
• Thyroid Cancer-Specific Quality of Life questionnaire [Срок оценки: From enrollment to the end of treatment at 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT06607133 · S2019-283-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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