A Single-Arm Clinical Study Evaluating Microwave Ablation of the Spleen Combined With Splenic Artery Occlusion for Secondary Hypersplenism Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Routine blood test
研究概览
简要总结
This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism.
详细描述
This open-label, single-arm, single-center clinical trial investigates the combined approach of microwave ablation of the spleen and splenic artery occlusion for managing secondary hypersplenism.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. written informed consent signed prior to enrolment
- •age > 18 years, both sexes 3.Patients with severe hypersplenism secondary to cirrhosis with clinical diagnosis, White blood cells <3×109/L, and/or platelet <50×109/L 4.Patients who have been repeatedly given drugs to raise white blood cells and platelets in clinical practice have poor effect 5.Mental problems such as clinical symptoms or anxiety in patients require interventional treatment for hypersplenism
排除标准
- •Patients with any of the following are not eligible for enrollment in this study
- •Coagulopathy or other blood disorders
- •Recent use of anticoagulant drugs
- •Severe hypertension and cardiac insufficiency
- •Bone marrow aspiration results showed bone marrow suppression
- •Combined with other spleen malignant diseases
- •Severe skin infection at the puncture site
- •Participated in other clinical studies within 2 months prior to the start of the study
- •Patient or his/her authorized person is unwilling to sign a written informed consent form or unwilling to comply with the study protocol
研究组 & 干预措施
microwave ablation of the spleen combined with splenic artery occlusion
The ablation puncture needle is percutaneously punctured into the spleen under ultrasound guidance, and the ablation method of one needle and multi-point method and needle insertion and pulling is mostly used
干预措施: microwave ablation of the spleen (Procedure)
microwave ablation of the spleen combined with splenic artery occlusion
The ablation puncture needle is percutaneously punctured into the spleen under ultrasound guidance, and the ablation method of one needle and multi-point method and needle insertion and pulling is mostly used
干预措施: Splenic artery balloon implantation (Other)
结局指标
主要结局
Routine blood test
时间窗: Up to 1 year
Platelet count
Adverse Events
时间窗: Up to 1 year
Adverse Events
Dynamic changes in platelet and white blood cell counts in routine blood tests
时间窗: Up to 1 year
Platelet and WBC count changes on CBC
Hepatic artery blood flow velocity
时间窗: Up to 1 year
Hepatic artery blood flow velocity
次要结局
未报告次要终点