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临床试验/NCT06607133
NCT06607133尚未招募不适用

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

Ming-an Yu1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
volume reduction ratio

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

volume reduction ratio

时间窗: From enrollment to the end of treatment at 12 months

The volume reduction ratio(VRR) = \[(preoperative volume - volume at the follow-up point)/preoperative volume\] × 100%. The volumes of the nodules were calculated using the following equation: V=π/6 a×b×c (where V is the volume, a is the maximum diameter, b and c are the other two perpendicular diameters).

Complications

时间窗: From enrollment to the end of treatment at 12 months

Complications related to thermal ablation or thyroidectomy during treatment procedures, at the hospital stay and follow-ups.

次要结局

  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(From enrollment to the end of treatment at 12 months)
  • Thyroid Cancer-Specific Quality of Life questionnaire(From enrollment to the end of treatment at 12 months)

研究者

发起方
Ming-an Yu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ming-an Yu

Head of the Department of Interventional Medicine

China-Japan Friendship Hospital

研究点 (1)

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