Ultrasound Guided Partial Microwave Ablation of the Spleen Due to Secondary Splenomegaly in Children - a Study of Feasibility and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Platelet count
研究概览
简要总结
Children with liver cirrhosis frequently develops portal hypertension. One of the serious complications to portal hypertension is splenomegaly, which may result in pancytopenia, especially thrombocytopenia that may cause bleeding tendencies.
Symptomatic splenomegaly is often treated with partial splenic embolization (PSE). PSE is effective but may give rise to postembolization syndrome not well tolerated in the pediatric population. In adults, microwave ablation (MWA) has been used to treat splenomegaly with promising results but with less post-operative pain. Our study is a pilot trial to evaluate the feasibility and acceptability of this treatment in children.
详细描述
The ablation will be performed under general anesthesia by an experienced interventional radiologist. Ultrasound will be used for peri-operative assessment and the microwave antenna will be inserted under ultrasound guidance focusing on the middle to inferior part of the spleen to avoid harm to the diaphragm. After the emission of microwaves for up to 5 minutes, the antenna will be pulled back and the emission will be repeated until the ablation zone is approximately 1 cm from the splenic surface. In this way, two or three overlapping areas will be ablated with every insertion of the antenna. The ablation zones will be visible as hyperechoic areas on b-mode ultrasound during operation, and the goal is to ablate up to 40-50% of the total volume of the spleen (as estimated by the radiologist). If the ablated volume is less than 40-50% at follow up, the procedure can be repeated in a second session for additional effect.
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spleen length > +2 standard deviations of normal limit
- •Platelet count below 30-35 x 109 cells/L and a history of bleeding tendencies
- •Symptoms of portal hypertension such as splenomegaly, thrombocytopenia, leucopenia, ascites, esophageal or gastric varices, hypertensive gastropathy, anal hemorrhoids and increased portal scintigraphy index, where alternative methods have not been enough or suitable
- •A necessity for reduction of splenic volume due to splenic inhibition of motion and activity in the child
排除标准
- •Age younger than 10 or older than 17 years of age
- •Legal guardians or child do not give consent
- •Ongoing infection
结局指标
主要结局
Platelet count
时间窗: Base line and 1, 3, 6 and 12 months follow up
Difference between platelet count before MWA and at 1, 3, 6 and 12 months after treatment
次要结局
- Acceptability of treatment(1 month after ablation)
- Number of MWA(Within 12 months)
- Effect on blood cell count(Base line and 1, 3, 6 and 12 months follow up)
- Effect on liver function(Base line and 1, 3, 6 and 12 months follow up)
- Effect on coagulation(Base line and 1, 3, 6 and 12 months follow up)
- Maximal pain(Day of surgury and the following 7 days)
- Use of analgesic drugs(Day of surgury and the following 7 days)
- Days of hospitalization(1 month)
研究者
Thomas Casswall
Clinical Professor
Karolinska Institutet