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临床试验/NCT06729762
NCT06729762招募中不适用

Ultrasound-guided Thermal Ablation for the Treatment of Benign Thyroid Nodules: A Multicenter Study

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 1,500 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
1,500
试验地点
1
主要终点
volume reduction rate

研究概览

简要总结

To evaluate long-term outcomes of ultrasound-guided thermal ablation for benign thyroid nodules

详细描述

To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for benign thyroid nodules by a multicenter study

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

入选标准

  • confirmation of benign nodule status on two separate fine- needle aspiration or core-needle biopsy
  • no suspicious malignant features on ultrasound examination
  • report of cosmetic and/ or symptomatic problems or concern of nodules growing rapidly or malignant transformation
  • refusal or ineligibility for surgery
  • follow-up time ≥12 months

排除标准

  • follicular neoplasm or malignancy findings on biopsy
  • nodules with benign result on biopsy had suspicious of malignancy in US
  • patients with contra-lateral vocal cord paralysis
  • previous radiation to the head and neck
  • 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)
  • cosmetic score(through study completion, an average of 6 months)
  • symptom score(through study completion, an average of 6 months)
  • 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 disappearance(through study completion, an average of 6 months)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu-kun Luo

Clinical Professor

Chinese PLA General Hospital

研究点 (1)

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