NCT06733753招募中不适用
Ultrasound-guided Thermal Ablation for Bethesda III/IV Thyroid Nodules: A Multicenter Study
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年12月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- volume reduction rate
研究概览
简要总结
To evaluate the long-term outcomes of ultrasound-guided thermal ablation for Bethesda III/IV thyroid nodules
详细描述
To evaluate and predict the long-term clinical outcomes of ultrasound-guided thermal ablation for Bethesda III/IV 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmation of Bethesda III or IV on fine- needle aspiration and negative on Braf V600E test
- •no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
- •refusal or ineligibility for surgery
- •follow-up time ≥12 months
排除标准
- •follicular neoplasm or malignancy findings on biopsy
- •no suspicious of malignancy in US
- •patients with contra-lateral vocal cord paralysis
- •follow- up time less than 12 months
结局指标
主要结局
volume reduction rate
时间窗: through study completion, an average of 6 months
The volume reduction rate (VRR)was calculated by the equations: VRR=(\[initial volume-final volume\] × 100)/initial volume
次要结局
- rate of complications(1 week)
- rate of nodule regrowth(through study completion, an average of 6 months)
- rate of change of thyroid function(through study completion, an average of 6 months)
- rate of delayed surgery(through study completion, an average of 1 year)
- cosmetic score(through study completion, an average of 6 months)
- symptom score(through study completion, an average of 6 months)
- rate of disappearance(through study completion, an average of 6 months)
研究者
Yu-kun Luo
Clinical Professor
Chinese PLA General Hospital
研究点 (1)
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