NCT07258199Enrolling By Invitation不适用
Transarterial Chemoembolization With Bleomycin: A Promising Treatment of Giant Nodular Goiter
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- volume
研究概览
简要总结
transarterial bleomycin chemoembolization represents a novel minimally invasive therapeutic approach for the management of giant nodular goiter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Clinical criteria: thyroid enlargement, mostly painless, with compressive symptoms (such as dysphagia, dyspnea) being less common; thyroid function is mostly normal, and a small number may be accompanied by hyperthyroidism or hypothyroidism.
- •Imaging examinations: ultrasound shows multiple solid or cystic-solid nodules with clear boundaries and no malignant signs such as microcalcification and a vertical-to-horizontal diameter ratio >
- •Pathological criteria: follicular epithelial cell hyperplasia, no nuclear atypia, and no malignant cellular characteristics (such as mitotic figures, infiltrative growth, etc.). In this study, a thyroid goiter with at least one diameter exceeding 4 cm was considered a giant goiter
排除标准
- •abnormal coagulation profiles;
- •hepatic or renal impairment;
- •allergy to contrast media;
- •refusal of interventional therapy and requirement for surgical treatment or other therapies
结局指标
主要结局
volume
时间窗: 1-, 3-, 6-, 12-month follow up
Lesion volume measurement on contrast-enhanced CT
次要结局
- longest diameter(1-, 3-, 6-, 12-month follow-up)
- lesion shrinkage(1-, 3-, 6-, 12-month follow-up)
研究者
研究点 (1)
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