CTRI/2025/09/094510尚未招募不适用
Effectiveness of Bleomycin-Lipiodol Transarterial Chemoembolization Therapy in Hepatic Hemangioma: A Pilot Non-Randomised Controlled Trial
未提供1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Size reduction
研究概览
简要总结
This study is a non randomised, parallel arms, single centre, active-controlled trial for assessment of the effectiveness of Bleomycin Lipiodol Transarterial Chemoembolization (TACE) in patients with giant or symptomatic hepatic hemangioma that will be conducted in India at a single tertiary care centre (All India Institute of Medical Sciences, New Delhi), in comparison to patients receiving only symptomatic medical management . The primary outcome will be measurement of size reduction at 6 months. The secondary outcomes will be to assess symptomatic resolution at 6 months and to assess the post procedural complications associated with TACE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years Patients with imaging diagnosis of typical hemangioma of size more than 5 cm or who are symptomatic Patients willing to give consent for the study.
排除标准
- •Age less than 18 years Pregnant patients Patients with asymptomatic Hepatic Hemangioma measuring less than 5 cm Patients diagnosed with suspected Hemangioma with imaging revealing alternate diagnosis.
- •Patients who have received any form of treatment in past for Hepatic Hemangioma.
结局指标
主要结局
Size reduction
时间窗: 6 months
次要结局
- Procedural complications(Post procedural period)
- Symptomatic resolution(6 months)
研究者
Dr Kaushal Jain
All India Institute of Medical Sciences, New Delhi
研究点 (1)
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